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

Tester, Defibrillator

21 CFR 870.5325 / Cardiovascular
FDA source (opens on fda.gov)

DRL is the FDA product code for Tester, Defibrillator, a class II device type, regulated under 21 CFR 870.5325. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
DRL
Device name
Tester, Defibrillator
Regulation
21 CFR 870.5325
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
19
Ingested recalls
1

Clearances, product code DRL

By decision year
19 clearances under product code DRL with a decision year between 1978 and 2019, 1990 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DRL by decision year
YearClearances
19781
19791
19881
19902
19911
19931
19941
19951
19961
19971
20031
20071
20082
20111
20151
20181
20191

Applicants with the most clearances

Product code DRL
Applicants holding the most 510(k) clearances under product code DRL
ApplicantClearances
BC Group International Inc2
Bio-Tek Instruments, Inc.2
Fluke Biomedical2
Guardian Angel Products, Inc.2
Netech Corp.2
Datrend Systems Inc1
Dynatech/Nevada, Inc.1
First Medical Devices Corp.1
Hogan & Hartson1
Instrumentation Laboratory Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code