Medical Device Manufacturer · US , Tewksbury , MA

Instrumentarium Corp.

20 submissions · 20 cleared · Since 1983
20
Total
20
Cleared
0
Denied

Instrumentarium Corp. — FDA 510(k) Submissions

Instrumentarium Corp. has submitted 20 FDA 510(k) premarket notifications since 1983, of which 20 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Unit, X-ray, Extraoral With Timer, System, Nuclear Magnetic Resonance Imaging, System, X-ray, Mammographic, System, X-ray, Extraoral Source, Digital, Analyzer, Gas, Carbon-dioxide, Gaseous-phase . Use the specialty filter in the sidebar to narrow results.

20 devices
1–20 of 20
MODIFICATION TO FOCUS
K022630 · EHD Unit, X-ray, Extraoral... · Radiology
Oct 2002 63d
FOCUS
K001729 · EHD Unit, X-ray, Extraoral... · Radiology
Jul 2000 36d
ORTHOCEPH OC100 D
K001439 · MUH System, X-ray, Extraoral... · Radiology
Jun 2000 45d
ORTHOPANTOMOGRAPH OP100D
K992385 · MUH System, X-ray, Extraoral... · Radiology
Sep 1999 74d
MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ
K981641 · IZH System, X-ray, Mammographic · Radiology
Jul 1998 70d
TONOCAP, TC-200 AND ACCESSORY CATHETERS
K962638 · CCK Analyzer, Gas,... · Anesthesiology
Apr 1997 273d
TONOMETERED SLAINE BLOOD GAS CONTROL
K961441 · JJS Controls For Blood-gases,... · Chemistry
Apr 1996 15d
TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR
K955018 · FFT Electrode, Ph, Stomach · Gastroenterology & Urology
Jan 1996 89d
ALPHA STEREO
K934478 · IZH System, X-ray, Mammographic · Radiology
Jan 1995 504d
AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE
K923433 · CBQ Analyzer, Gas, Enflurane,... · Anesthesiology
Jul 1993 374d
ORTHOCEPH OC100
K930338 · EHD Unit, X-ray, Extraoral... · Radiology
Apr 1993 92d
ORTHOPANTOMOGRAPH 100
K912893 · EHD Unit, X-ray, Extraoral... · Radiology
Nov 1991 127d
CARDIOCAP II TM CH-RESP MONITORS
K904355 · DPS Electrocardiograph · Cardiovascular
May 1991 241d
INSTRUMENTARIUM ULF MR IMAGING SYSTEM
K883621 · LNH System, Nuclear Magnetic... · Radiology
Nov 1988 77d
INSTRUMENTARIUM ULF MR IMAGING SYSTEM MODEL 110H
K883649 · LNH System, Nuclear Magnetic... · Radiology
Oct 1988 51d
INSTRUMENTARIUM ULF MR IMAGING SYSTEM VERSION 110
K883650 · LNH System, Nuclear Magnetic... · Radiology
Sep 1988 18d
INSTRUMENTARIUM ULF MR IMAGING SYSTEM
K883622 · LNH System, Nuclear Magnetic... · Radiology
Sep 1988 20d
CARDIOCAP MONITOR
K853953 · DRT Monitor, Cardiac (incl.... · Cardiovascular
Jun 1986 250d
MULTICAP MULTIGAS CAPNOMETER PB252
K853396 · CCK Analyzer, Gas,... · Anesthesiology
Aug 1985 4d
CD-102 CARBON DIOXIDE ANALYZER/RECOR
K833739 · CCJ Analyzer, Gas,... · Anesthesiology
Dec 1983 52d
Filters