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
25–48 of 87
Cleared Dec 22, 1983
MONITORING SYSTEM AS100-AS115 RECORD
K832754
Air-Shields, Inc.
Cardiovascular · 128d
Cleared Oct 31, 1983
MEDICAL ELECTRONICS-PRINTER CLOCK
K832012
Litton Medical Electronics
Cardiovascular · 130d
Cleared Mar 31, 1983
DUAL CHANNEL RECORDER #78574A
K830315
Hewlett-Packard Co.
Cardiovascular · 59d
Cleared Dec 15, 1982
MINGOGRAF 4, MINGO CARD 4 & MINOCARD 3
K822978
Siemens Corp.
Cardiovascular · 68d
Cleared Nov 24, 1982
MINGOCARD 7 & MINGOPHONE 7
K822983
Siemens Corp.
Cardiovascular · 47d
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 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 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