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

Alarm, Leakage Current, Portable

21 CFR 870.2640 / Cardiovascular
FDA source (opens on fda.gov)

DSM is the FDA product code for Alarm, Leakage Current, Portable, a class I device type, regulated under 21 CFR 870.2640. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
DSM
Device name
Alarm, Leakage Current, Portable
Regulation
21 CFR 870.2640
Device class
Class I
Review panel
Cardiovascular
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code DSM

By decision year
1 clearance under product code DSM with a decision year between 1978 and 1978, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DSM by decision year
YearClearances
19781

Applicants with the most clearances

Product code DSM
Applicants holding the most 510(k) clearances under product code DSM
ApplicantClearances
Cardio-Dynamics Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code