510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DRTClass II

Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

21 CFR 870.2300 / Cardiovascular
FDA source (opens on fda.gov)

DRT is the FDA product code for Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a class II device type, regulated under 21 CFR 870.2300. As of , FDA records hold 339 510(k) clearances under this code, the most recent dated , and 11 recalls.

Classification record

Product code
DRT
Device name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Regulation
21 CFR 870.2300
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
340
Ingested recalls
11

Clearances, product code DRT

By decision year
340 clearances under product code DRT with a decision year between 1976 and 2026, 1983 the highest year at 29.
Show the numbers
510(k) clearances under FDA product code DRT by decision year
YearClearances
19768
197711
197812
197917
198011
198114
198228
198329
198425
198527
198619
19875
19888
198918
199012
199113
19923
19932
19946
19957
19963
19974
19984
19993
20001
20015
20024
20031
20041
20054
20062
20071
20081
20096
20103
20113
20121
20131
20151
20161
20171
20181
20191
20212
20221
20231
20243
20251
20264

Applicants with the most clearances

Product code DRT
Applicants holding the most 510(k) clearances under product code DRT
ApplicantClearances
Hewlett-Packard Co.20
Litton Medical Electronics17
Ivy Biomedical Systems, Inc.10
Life Science Instrumentation, Inc.10
Nihon Kohden America Inc10
S & W Medico Teknik8
Datascope Corp.7
GE Medical Systems Information Technologies, Inc.6
Honeywell, Inc.6
Rigel Medical Electronics, Inc.6

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 94 companies shown, in name order