Medical Device Manufacturer · US , Mchenry , IL

Electromedics, Inc.

41 submissions · 41 cleared · Since 1977
41
Total
41
Cleared
0
Denied

Electromedics, Inc. — FDA 510(k) Submissions

Electromedics, Inc. has submitted 41 FDA 510(k) premarket notifications since 1977, of which 41 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Continuous Measurement Thermometer, Apparatus, Autotransfusion, Reservoir, Blood, Cardiopulmonary Bypass, Heat-exchanger, Cardiopulmonary Bypass, Filter, Blood, Cardiopulmonary Bypass, Arterial Line . Use the specialty filter in the sidebar to narrow results.

41 devices
1–25 of 41
ELECTROMEDICS TYMPANIC TEMPERATURE SENSOR
K934964 · FLL Continuous Measurement... · General Hospital
Mar 1994 143d
ELECTROMEDICS HG (HYDROGEL) SERIES SKIN TEMPERATURE SENSOR
K933832 · FLL Continuous Measurement... · General Hospital
Jan 1994 176d
ELECTROMEDICS BLOOD HEAT EXCHANGER
K934355 · DTR Heat-exchanger,... · Cardiovascular
Dec 1993 87d
EL2-SERIES BLOOD COLLECTION REERVOIR
K930154 · DTN Reservoir, Blood,... · Cardiovascular
Jul 1993 169d
ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR
K926250 · DTN Reservoir, Blood,... · Cardiovascular
Feb 1993 67d
ELECTROMEDICS TISSUE TRAP/ #TT280
K925412 · BYZ Trap, Sterile Specimen · General Hospital
Feb 1993 102d
AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR
K915737 · DTN Reservoir, Blood,... · Cardiovascular
Sep 1992 258d
PORTABLE AUTO TRANSFUSION SYSTEM 500
K910238 · CAC Apparatus, Autotransfusion · Anesthesiology
Jun 1991 152d
MODIFIED PYROGEN TESTING
K910935 · DTM Filter, Blood,... · Cardiovascular
May 1991 91d
ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20
K902723 · DTM Filter, Blood,... · Cardiovascular
Dec 1990 177d
ELECTROMEDICS BT422-120 AND BT422-40
K903392 · CAC Apparatus, Autotransfusion · Anesthesiology
Sep 1990 41d
AP900/PRP MODULE AND ACCESSORIES, MODIFICATION
K893218 · CAC Apparatus, Autotransfusion · Anesthesiology
Jun 1990 411d
TCPM II TOURNIQUET CUFF PRESSURE MONITOR
K900104 · KCY Tourniquet, Pneumatic · General & Plastic Surgery
Mar 1990 65d
ELECTROMEDICS D1079E
K873561 · DTR Heat-exchanger,... · Cardiovascular
Nov 1987 64d
BT-795/ATS
K871847 · CAC Apparatus, Autotransfusion · Anesthesiology
Jun 1987 38d
BT-795/P AUTOMATED AUTOTRANS
K860306 · CAC Apparatus, Autotransfusion · Hematology
Mar 1986 37d
ACR 2500 CARDIOTOMY RESERVOIR FILTER
K842391 · DTN Reservoir, Blood,... · Cardiovascular
May 1985 337d
POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTE
K844803 · DTP Defoamer, Cardiopulmonary... · Cardiovascular
Apr 1985 139d
MODEL TTPM TIME TEMP. PRESSURE MONITOR
K832897 · DRS Transducer,... · Cardiovascular
Mar 1984 213d
TOURNIQUET CUFF PRESSURE MONITOR #TCPM
K832272 · LDQ · General & Plastic Surgery
Nov 1983 139d
CARDIOPLEGIA RECIRCULATION SYS-BL 705/A
K831458 · DWB Pump, Blood,... · Cardiovascular
Oct 1983 167d
STERILE FOLEY CATHETERS & UROLOGICAL
K831743 · KOD Catheter, Urological · Gastroenterology & Urology
Sep 1983 104d
HI FLEX D-700 MODULAR BUBBLE OXYGENA-
K830639 · DTZ Oxygenator,... · Cardiovascular
May 1983 85d
DISPOS. TYPE T THERMOCOUPLE TEMP.PROBE
K830592 · FLL Continuous Measurement... · General Hospital
May 1983 83d
BT 795/A AUTOTRANS
K830735 · CAC Apparatus, Autotransfusion · Anesthesiology
May 1983 55d
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