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

FDA 510(k) Cleared Recorder, Paper Chart Devices (Product Code DSF)

87 devices
1–24 of 87
Cleared Aug 29, 1991
EDENTEC DIGITAL CHARTER MODEL 3710
K910871
Edentec Corp.
Cardiovascular · 181d
Cleared Jan 11, 1991
MODEL 556 MONITOR
K905856
Ge Medical Systems Information Technologies
Cardiovascular · 88d
Cleared Jun 19, 1990
COLORADO COLOR IMAGING RECORDER
K902230
Honeywell, Inc.
Cardiovascular · 33d
Cleared Jan 26, 1990
TYPE 9541 RECORDER, PAPER CHART
K895111
S & W Medico Teknik
Cardiovascular · 176d
Cleared Aug 25, 1989
EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM.
K893561
Edentec Corp.
Cardiovascular · 108d
Cleared Jul 14, 1989
CARDIOCAP(TM) DR-104 REPORTER
K885058
Datex Division Instrumentarium Corp.
Cardiovascular · 219d
Cleared Mar 09, 1989
FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER
K884897
Mennen Medical, Inc.
Cardiovascular · 106d
Cleared Jan 10, 1989
EDENTEC MODEL 4700 SCANNER
K884388
Edentec Corp.
Cardiovascular · 84d
Cleared Dec 28, 1988
EDENTRACE MULTI-CHARTER MODEL 3700
K883315
Edentec Corp.
Cardiovascular · 145d
Cleared Jul 14, 1988
WS 800R THERMAL ARRAY RECORDER
K881831
Nihon Kohden America, Inc.
Cardiovascular · 76d
Cleared Jun 09, 1988
LIFESTAT 1600 PRINTER
K881346
Physio-Control Corp.
Cardiovascular · 71d
Cleared May 11, 1988
DATALOGGER CHART RECORDER
K880781
Air-Shields, Inc.
Cardiovascular · 75d
Cleared May 06, 1988
VSM(R) R2 PAPER CHART RECORDER
K880554
Physio-Control Corp.
Cardiovascular · 87d
Cleared Nov 04, 1987
MODEL 78576A PAPER CHART RECORDER
K872822
Hewlett-Packard Co.
Cardiovascular · 110d
Cleared Oct 06, 1986
SIREDOC 60 AND SIREDOC 220
K863331
Siemens Medical Solutions USA, Inc.
Cardiovascular · 40d
Cleared May 16, 1986
MODEL 535 NEO-TRAK RECORDER
K855045
Ge Medical Systems Information Technologies
Cardiovascular · 150d
Cleared Apr 09, 1986
LONG TERM RECORDER RAG 1200
K854866
Nihon Kohden America, Inc.
Cardiovascular · 152d
Cleared Sep 19, 1985
FUKUDA DENSHI MODEL AU-5001-5003 THERMAL
K852487
Fukuda Denshi USA, Inc.
Cardiovascular · 100d
Cleared May 15, 1985
OHMEDA MODEL 0001/0003 RECORDER
K851274
Ohmeda Medical
Cardiovascular · 44d
Cleared Mar 29, 1985
NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER
K850487
Novametrix Medical Systems, Inc.
Cardiovascular · 50d
Cleared Feb 12, 1985
SIREDOC, PAPER CHART RECORDER
K850146
Siemens Medical Solutions USA, Inc.
Cardiovascular · 29d
Cleared Oct 19, 1984
THERMAL GRAYSCALE RF-100
K843836
Fukuda Denshi USA, Inc.
Cardiovascular · 18d
Cleared Jun 01, 1984
2-CHANNEL RECORDER
K832998
Litton Medical Electronics
Cardiovascular · 288d
Cleared Jun 01, 1984
I-CHANNEL RECORDER
K833000
Litton Medical Electronics
Cardiovascular · 288d

About Product Code DSF - Regulatory Context