510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021389Substantially Equivalent

Biological Sound Monitor (Bsm) Sensor

Andromed, Inc., Saint Laurent, Quebec, CA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K021389 is the FDA 510(k) clearance record for BIOLOGICAL SOUND MONITOR (BSM) SENSOR, a class II device, cleared for Andromed, Inc. on under FDA product code DQD (Stethoscope, Electronic). FDA records list 5 510(k) clearances for Andromed, Inc., from to . As of , FDA records show no recalls naming K021389.

Clearance record

Decision date
Received
(152 days to decision)
Product code
DQD Stethoscope, Electronic
Regulation
21 CFR 870.1875
Device class
Class II
Review panel
Cardiovascular
Applicant
Andromed, Inc. 4610 Chemin Du Bois-Franc, Saint Laurent, Quebec, CA
510(k) summary
Statement
Third party review
No

Clearances, product code DQD

Trailing 12 months
6 clearances under product code DQD in the twelve months to October 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DQD, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20261
April 20260
May 20261
June 20260
July 20262
August 20260
September 20260
October 20260