Medical Device Manufacturer · US , Mchenry , IL

Critikon Company, LLC - FDA 510(k) Cleared Devices

51 submissions · 51 cleared · Since 1979

51

Total

51

Cleared

0

Denied

FDA 510(k) Regulatory Record - Critikon Company, LLC Cardiovascular ✕

24 devices

1-12 of 24

Cleared Sep 21, 2000

DINAMAP PRO 1000 MONITOR, MODEL 1000

Cardiovascular · 58d

Cleared May 26, 2000

DINAMAP ADVANCED NIBP MODULE

Cardiovascular · 102d

Cleared Feb 24, 2000

DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400

Cardiovascular · 202d

Cleared Aug 14, 1998

DINAMAP MPS SELECT PORTABLE MONITOR

Cardiovascular · 39d

Cleared Jun 16, 1995

DINAMAP PLUS VITAL SIGNS MONOITOR

Cardiovascular · 319d

Cleared Mar 01, 1995

DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340

Cardiovascular · 266d

Cleared Feb 09, 1994

CRITIKON CENTRAL STATIN MONITOR

Cardiovascular · 212d

Cleared Jul 01, 1993

CRITIKON VITAL SIGNS MODULE

Cardiovascular · 556d

Cleared Dec 04, 1991

DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700

Cardiovascular · 201d

Cleared Dec 30, 1987

DINAMAP VITAL SIGNS MONITOR, MODEL 8100T

Cardiovascular · 65d

Cleared Jul 29, 1987

VITALNET(TM) SYSTEM (DINAMAP(TM), MODEL 2200)

Cardiovascular · 112d

Cleared May 16, 1986

DINAMAP VITAL SIGNS MONITOR MODEL 8100

Cardiovascular · 192d