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

Amplifier And Signal Conditioner, Biopotential

21 CFR 870.2050 / Cardiovascular
FDA source (opens on fda.gov)

DRR is the FDA product code for Amplifier And Signal Conditioner, Biopotential, a class II device type, regulated under 21 CFR 870.2050. As of , FDA records hold 24 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DRR
Device name
Amplifier And Signal Conditioner, Biopotential
Regulation
21 CFR 870.2050
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
24
Ingested recalls
0

Clearances, product code DRR

By decision year
24 clearances under product code DRR with a decision year between 1976 and 2002, 1977 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code DRR by decision year
YearClearances
19761
19774
19782
19793
19802
19812
19861
19881
19892
19912
19921
19931
19971
20021

Applicants with the most clearances

Product code DRR
Applicants holding the most 510(k) clearances under product code DRR
ApplicantClearances
Hewlett-Packard Co.5
Astro-Med, Inc.2
Quinton Electrophysiology Corp.2
Arzbaecher & Co.1
BioCheck Inc1
C-V Monitors Corp.1
C.R. Bard Inc1
Cardiac Pacemakers, Inc.1
Cerenovus, Inc.1
Consolidated Medical Equipment Company1

Companies listing this code with FDA

Companies whose registered establishments list this code