DSF · Class I · 21 CFR 870.2810

FDA Product Code DSF: Recorder, Paper Chart

Leading manufacturers include Honeywell, Inc., Hewlett-Packard Co. and Ge Medical Systems Information Technologies.

87
Total
87
Cleared
72d
Avg days
1976
Since
87 devices
25–48 of 87
Cleared Nov 01, 1982
CENTURION CHART RECORDER
K822432
Clinical Data, Inc.
Cardiovascular · 81d
Cleared Jul 14, 1982
MODEL 16800 TREND RECORDER
K821612
Healthdyne, Inc.
Cardiovascular · 42d
Cleared Jan 22, 1982
CARDIOVUE ACCESSORY CART
K820033
Diasonics, Inc.
Cardiovascular · 16d
Cleared Aug 13, 1981
SPACELABS' SYSTEM AUTORECORDER
K811540
Spacelabs, Inc.
Cardiovascular · 73d
Cleared Jul 10, 1981
PAPER CHART RECORDER
K811254
American Edwards Laboratories
Cardiovascular · 66d
Cleared Jul 10, 1981
NOVATRACER RECORDER
K811453
Novametrix Medical Systems, Inc.
Cardiovascular · 49d
Cleared Feb 25, 1981
1,2,3 CHANNELL RECORDERS (AR150,AR250,-)
K810166
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
SINGLE CHANNELL RECORDER AR110
K810167
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
CENTRAL STATION CONTROLLER AC100/CE100
K810169
Honeywell, Inc.
Cardiovascular · 34d
Cleared Jan 13, 1981
ADVANCEMED EXAMINER
K803225
American Edwards Laboratories
Cardiovascular · 25d
Cleared Aug 27, 1980
MODEL 9300 ELECTROCARDIOVALIDATOR
K801830
Del Mar Avionics
Cardiovascular · 26d
Cleared Oct 26, 1979
CRITIKON DUAL CHANNEL RECORDER
K792105
Critikon Company, LLC
Cardiovascular · 4d
Cleared May 31, 1979
LS-8 VISICORDER
K790825
Honeywell, Inc.
Cardiovascular · 31d
Cleared Jun 28, 1978
ECG PAPER, 3 CHANNEL
K780597
Abco Dealers, Inc.
Cardiovascular · 79d
Cleared Apr 28, 1978
DRY SILVER PROCESSOR MODEL 1226
K780640
Honeywell, Inc.
Cardiovascular · 11d
Cleared Mar 15, 1978
MINYSTAG MN-1
K780338
Lkb Instruments, Inc.
Cardiovascular · 14d
Cleared Feb 13, 1978
RECORDER, PAPER, ECG
K772333
Telectronics, Inc.
Cardiovascular · 53d
Cleared Nov 22, 1977
PHYSIOLOGICAL RECORDER MODEL 721A
K772052
Datascope Corp.
Cardiovascular · 22d
Cleared Nov 22, 1977
PHYSIOLOGICAL RECORDER MODEL 740
K772054
Datascope Corp.
Cardiovascular · 22d
Cleared Nov 09, 1977
SINGLE & DUAL CHANNEL RECORDER
K772048
Hewlett-Packard Co.
Cardiovascular · 16d
Cleared Jul 05, 1977
RECORD, MODEL 702, I.L.
K770946
Instrumentation Laboratory CO
Cardiovascular · 43d
Cleared Dec 09, 1976
CALCULATOR PLOTTER (MODEL 9872A)
K761055
Hewlett-Packard Co.
Cardiovascular · 24d
Cleared Oct 13, 1976
LIFEPAK 5 CARDIOSCOPE-RECORDER MODULE
K760676
Physio-Control Corp.
Cardiovascular · 23d
Cleared Sep 09, 1976
RECORDER (#78640A)
K760539
Hewlett-Packard Co.
Cardiovascular · 10d