JOM · Class II · 21 CFR 870.2780

FDA Product Code JOM: Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

Leading manufacturers include D. E. Hokanson, Inc., Biomedix, Inc. and Medasonics, Inc..

53
Total
53
Cleared
121d
Avg days
1976
Since
53 devices
25–48 of 53
Cleared Jun 12, 1987
PULSE CUFF RECORDER MODEL PCR100
K863702
Imex Medical Systems, Inc.
Cardiovascular · 262d
Cleared May 06, 1987
VASOPULSE(TM)/MODEL 5000
K863803
Sonicaid, Inc.
Cardiovascular · 219d
Cleared Jan 14, 1986
OSM-1 OXYGEN SATURATION MONITOR
K853331
Criticare Systems, Inc.
Cardiovascular · 159d
Cleared Nov 06, 1985
NOVAMETRIX PULSE OXIMETER, MODEL 500
K853124
Novametrix Medical Systems, Inc.
Cardiovascular · 104d
Cleared Dec 01, 1983
PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH
K832374
Sonicaid, Inc.
Cardiovascular · 136d
Cleared Aug 11, 1983
HR 100T
K831955
Thought Technology , Ltd.
Cardiovascular · 55d
Cleared Oct 02, 1981
VASCULAB #VSC21
K812609
Medasonics, Inc.
Cardiovascular · 17d
Cleared Jul 08, 1980
EC-4 PLETHYSMOGRAPH
K801291
D. E. Hokanson, Inc.
Cardiovascular · 36d
Cleared Feb 26, 1979
PLETHYSMOGRAPH, STRAIN GAUGE
K782132
Medasonics, Inc.
Cardiovascular · 61d