Medical Device Manufacturer · US , Mchenry , IL

Draeger Medical, Inc.

78 submissions · 77 cleared · Since 1977
78
Total
77
Cleared
0
Denied

Draeger Medical, Inc. — FDA 510(k) Submissions

Draeger Medical, Inc. has submitted 78 FDA 510(k) premarket notifications since 1977, of which 77 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Gas-machine, Anesthesia, Ventilator, Continuous, Facility Use, Vaporizer, Anesthesia, Non-heated, Analyzer, Gas, Carbon-dioxide, Gaseous-phase, Monitor, Airway Pressure (includes Gauge And/or Alarm) . Use the specialty filter in the sidebar to narrow results.

78 devices
1–25 of 78
PRIMUS US
K042607 · BSZ Gas-machine, Anesthesia · Anesthesiology
Nov 2004 63d
FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM
K042419 · BSZ Gas-machine, Anesthesia · Anesthesiology
Oct 2004 31d
D-VAPOR
K042276 · CAD Vaporizer, Anesthesia,... · Anesthesiology
Sep 2004 31d
FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM
K042086 · BSZ Gas-machine, Anesthesia · Anesthesiology
Aug 2004 28d
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM
K041622 · BSZ Gas-machine, Anesthesia · Anesthesiology
Jul 2004 22d
MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR
K040847 · CCK Analyzer, Gas,... · Anesthesiology
Jun 2004 77d
NARKOMED 6400, MODEL NM6400
K033498 · BSZ Gas-machine, Anesthesia · Anesthesiology
Apr 2004 173d
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM
K030624 · BSZ Gas-machine, Anesthesia · Anesthesiology
Mar 2004 384d
FABIUS TIRO ANESTHESIA SYSTEM
K031400 · BSZ Gas-machine, Anesthesia · Anesthesiology
Jul 2003 71d
NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2
K022031 · BSZ Gas-machine, Anesthesia · Anesthesiology
Aug 2002 69d
FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS
K011404 · BSZ Gas-machine, Anesthesia · Anesthesiology
Feb 2002 290d
VAMOS ANESTHETIC GAS MONITOR
K012139 · CCK Analyzer, Gas,... · Anesthesiology
Jan 2002 191d
NARKOMED MRI-2, MODEL NM-MRI-2
K003579 · BSZ Gas-machine, Anesthesia · Anesthesiology
Jan 2001 63d
NARKOMED MRI , NM-MRI
K001488 · BSZ Gas-machine, Anesthesia · Anesthesiology
Jun 2000 28d
NARKOMED 6000
K993826 · MLC Monitor, St Segment · Cardiovascular
Mar 2000 132d
JULIAN ANESTHESIA WORKSTATION, MODEL # JULIAN
K983635 · BSZ Gas-machine, Anesthesia · Anesthesiology
Jan 1999 88d
DIVAN ANESTHESIA VENTILATOR
K980208 · CBK Ventilator, Continuous,... · Anesthesiology
Aug 1998 196d
NARKOMED 6000 MODEL NUMBER NM6000
K980553 · BSZ Gas-machine, Anesthesia · Anesthesiology
Aug 1998 173d
DRAGER-VAPOR 19.3
K981773 · CAD Vaporizer, Anesthesia,... · Anesthesiology
Jul 1998 47d
BABYTHERM 8000 LDR
K980886 · FMZ Incubator, Neonatal · General Hospital
May 1998 81d
DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS
K981472 · CAD Vaporizer, Anesthesia,... · Anesthesiology
May 1998 13d
PERIOPERATIVE DATA MANAGEMENT SYSTEM
K973949 · BSZ Gas-machine, Anesthesia · Anesthesiology
Feb 1998 113d
NARKOMED ULTRASONIC FLOW SENSOR
K974193 · BSZ Gas-machine, Anesthesia · Anesthesiology
Jan 1998 82d
NARKOMED MRI ANESTHESIA SYSTEM
K972848 · BSZ Gas-machine, Anesthesia · Anesthesiology
Oct 1997 90d
DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS
K973051 · CAD Vaporizer, Anesthesia,... · Anesthesiology
Oct 1997 76d

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