510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DPSClass II

Electrocardiograph

21 CFR 870.2340 / Cardiovascular
FDA source (opens on fda.gov)

DPS is the FDA product code for Electrocardiograph, a class II device type, regulated under 21 CFR 870.2340. As of , FDA records hold 576 510(k) clearances under this code, the most recent dated , and 98 recalls.

Classification record

Product code
DPS
Device name
Electrocardiograph
Regulation
21 CFR 870.2340
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
577
Ingested recalls
98

Clearances, product code DPS

By decision year
577 clearances under product code DPS with a decision year between 1976 and 2026, 1986 the highest year at 27.
Show the numbers
510(k) clearances under FDA product code DPS by decision year
YearClearances
197616
19776
19785
197917
19809
198119
198213
198317
19849
198524
198627
198721
198816
198917
199017
19919
199210
19937
19947
19958
199614
199710
199813
19992
20009
200116
200210
20039
20044
200513
200610
200711
200813
200914
201011
201122
201212
201310
201411
20158
201611
20179
201814
20193
20206
20215
20226
202310
20248
20256
20263

Applicants with the most clearances

Product code DPS
Applicants holding the most 510(k) clearances under product code DPS
ApplicantClearances
Mortara Instrument, Inc.21
Nihon Kohden America Inc21
Edan Instruments, Inc.19
Quinton, Inc.17
Hewlett-Packard Co.15
Burdick Corp.12
Marquette Electronics, Inc.10
Philips North America LLC10
GE Medical Systems Information Technologies, Inc.9
Cambridge Heart, Inc.8

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 166 companies shown, in name order