DRT · Class II · 21 CFR 870.2300

FDA Product Code DRT: Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

Leading manufacturers include Hewlett-Packard Co., Litton Medical Electronics and Ivy Biomedical Systems, Inc..

341
Total
341
Cleared
123d
Avg days
1976
Since
341 devices
121–144 of 341
Cleared Apr 26, 1989
TYPE 9210 ECG SYSTEM ATHENA
K884117
S & W Medico Teknik
Cardiovascular · 208d
Cleared Mar 09, 1989
MODEL 702 ECG/RESPIRATION/TEMPERATURE
K884455
Ivy Biomedical Systems, Inc.
Cardiovascular · 136d
Cleared Feb 23, 1989
PATIENT MONITOR MODEL 701
K884096
Ivy Biomedical Systems, Inc.
Cardiovascular · 148d
Cleared Feb 02, 1989
PATIENT MONITOR RIGEL MODEL MULTICARE 429
K884645
Rigel Medical Electronics, Inc.
Cardiovascular · 87d
Cleared Jan 19, 1989
MODELS M1175A & M1176A COMPONENT MONITORING SYSTEM
K882609
Waltham Div. Hewlett Packard
Cardiovascular · 206d
Cleared Jan 17, 1989
MINIMON 7134B PATIENT MONITOR
K883069
Kontron Instruments, Inc.
Cardiovascular · 181d
Cleared Jan 17, 1989
MINIMON 7136B PATIENT MONITOR
K883109
Kontron, Inc.
Cardiovascular · 176d
Cleared Dec 27, 1988
PROPAQ 106(TM)
K884320
Protocol Systems, Inc.
Cardiovascular · 75d
Cleared Jun 28, 1988
RIGEL MODEL MULTICARE 409
K875160
Rigel Medical Electronics, Inc.
Cardiovascular · 196d
Cleared Jun 15, 1988
MONITRON SYSTEM
K874148
American Health Products, Inc.
Cardiovascular · 246d
Cleared May 13, 1988
RM-301 PATIENT MONITOR
K880498
Ppg Industries, Inc.
Cardiovascular · 98d
Cleared Mar 22, 1988
MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR
K880066
Ivy Biomedical Systems, Inc.
Cardiovascular · 71d
Cleared Mar 07, 1988
MONITOR, ELECTROGRAPHIC
K874319
Medac, Inc.
Cardiovascular · 138d
Cleared Feb 09, 1988
CARE TELSTAT MODELS: MP 5010 AND MP 5020
K874844
Care Systems, Inc.
Cardiovascular · 77d
Cleared Jan 29, 1988
HEALTHDYNE APNEA/HEART MONITOR, MODEL 900
K874695
Healthdyne, Inc.
Cardiovascular · 74d
Cleared Jul 21, 1987
SIRECUST MODEL 960 AND 961 PATIENT MONITORING
K872249
Medical Electronics Laboratories, Inc.
Cardiovascular · 39d
Cleared Jul 21, 1987
SERIES 2000 BEDSIDE PATIENT MONITOR
K872354
Marquette Electronics, Inc.
Cardiovascular · 33d
Cleared Jul 21, 1987
COMPANION 50 REGULATOR/FLOWMETER
K872443
Puritan Bennett Corp.
Cardiovascular · 28d
Cleared Jun 05, 1987
DRM 2300 PLETHYSMOGRAPHIC CARDIOTACHOMETER
K871149
Iontec Corp.
Cardiovascular · 74d
Cleared Mar 20, 1987
PM-8 HEART RATE MONITOR
K864748
Pulse Time Products, Ltd.
Cardiovascular · 105d
Cleared Dec 22, 1986
M700 STRESS MONITOR
K863466
Kone Instruments, Inc.
Cardiovascular · 105d
Cleared Dec 22, 1986
NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20
K863494
Advantage Medical Systems, Inc.
Cardiovascular · 104d
Cleared Dec 05, 1986
LIFESCOPE 8, OEC-8120 PORTABLE PATIENT MONITOR REC
K862463
Nihon Kohden America, Inc.
Cardiovascular · 158d
Cleared Dec 04, 1986
DIGITAL PULSE METER HRM-100E & ETC.
K850449
Sanyo Electric, Inc.
Cardiovascular · 667d