DSF · Class I · 21 CFR 870.2810

FDA Product Code DSF: Recorder, Paper Chart

Leading manufacturers include Honeywell, Inc., Hewlett-Packard Co. and Edentec Corp..

87
Total
87
Cleared
72d
Avg days
1976
Since
87 devices
49–72 of 87
Cleared Nov 24, 1982
MODEL 525 NEO-TRAK NEONATAL RECORDER
K823210
Ge Medical Systems Information Technologies
Cardiovascular · 27d
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 May 18, 1982
EVENTMASTER 3 HOLTER EVENT SCANNER
K821173
Instruments For Cardiac Research
Cardiovascular · 22d
Cleared Jan 22, 1982
CARDIOVUE ACCESSORY CART
K820033
Diasonics, Inc.
Cardiovascular · 16d
Cleared Oct 02, 1981
VASCULAB #R12B
K812608
Medasonics, Inc.
Cardiovascular · 17d
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 Jul 14, 1980
MODEL R11 SINGLE CHANNEL CHART RECORDER
K801549
Medasonics, Inc.
Cardiovascular · 7d
Cleared Jul 08, 1980
SERIES 602 CKG RECORDER (MODIFIED)
K801485
Cardio Kinetics, Inc.
Cardiovascular · 14d
Cleared Apr 24, 1980
SERIES 602 CKGTM RECORDER
K800851
Cardio Kinetics, Inc.
Cardiovascular · 9d
Cleared Oct 26, 1979
50MM WRITER MODEL CVM 9529
K792099
C-V Monitors Corp.
Cardiovascular · 7d
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 Jan 05, 1979
WRITER, GEMINI-3
K781867
C-V Monitors Corp.
Cardiovascular · 63d
Cleared Jan 05, 1979
RECORDER, STRIP CHART WITH PRINTER
K781873
Midwest Analog & Digital, Inc.
Cardiovascular · 63d
Cleared Oct 06, 1978
PRINTER, DIGITAL
K781115
Output, Inc.
Cardiovascular · 95d
Cleared Jun 28, 1978
ECG PAPER, 3 CHANNEL
K780597
Abco Dealers, Inc.
Cardiovascular · 79d