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

Adaptor, Lead Switching, Electrocardiograph

21 CFR 870.2350 / Cardiovascular
FDA source (opens on fda.gov)

DRW is the FDA product code for Adaptor, Lead Switching, Electrocardiograph, a class II device type, regulated under 21 CFR 870.2350. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DRW
Device name
Adaptor, Lead Switching, Electrocardiograph
Regulation
21 CFR 870.2350
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
8
Ingested recalls
0

Clearances, product code DRW

By decision year
8 clearances under product code DRW with a decision year between 1976 and 2004, 1985 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DRW by decision year
YearClearances
19761
19852
19861
19871
19941
20021
20041

Applicants with the most clearances

Product code DRW
Applicants holding the most 510(k) clearances under product code DRW
ApplicantClearances
Eaton Medical Group2
Philips North America LLC2
Physio Control, Inc.1
Siemens Medical Solutions USA, Inc.1
Totemite Medical Electronics1
Vital Signs, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code