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

Dc-Defibrillator, High Energy, (Including Paddles)

21 CFR 870.5300 / Cardiovascular
FDA source (opens on fda.gov)

DRK is the FDA product code for Dc-Defibrillator, High Energy, (Including Paddles), a class III device type, regulated under 21 CFR 870.5300. FDA's definition for this code reads: "PMA to be filed by 12/26/96 (FR 50706 (9/27/96))". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
DRK
Device name
Dc-Defibrillator, High Energy, (Including Paddles)
FDA definition
PMA to be filed by 12/26/96 (FR 50706 (9/27/96))
Regulation
21 CFR 870.5300
Device class
Class III
Review panel
Cardiovascular
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code DRK

By decision year
1 clearance under product code DRK with a decision year between 1993 and 1993, 1993 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DRK by decision year
YearClearances
19931

Applicants with the most clearances

Product code DRK
Applicants holding the most 510(k) clearances under product code DRK
ApplicantClearances
National Custom Ent., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code