510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894161Substantially Equivalent

Asc-950 ECG Amplifier

Astro-Med, Inc., West Warwick RI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894161 is the FDA 510(k) clearance record for ASC-950 ECG AMPLIFIER, a class II device, cleared for Astro-Med, Inc. on under FDA product code DRR (Amplifier And Signal Conditioner, Biopotential). FDA records list 13 510(k) clearances for Astro-Med, Inc., from to . As of , FDA records show no recalls naming K894161.

Clearance record

Decision date
Received
(50 days to decision)
Product code
DRR Amplifier And Signal Conditioner, Biopotential
Regulation
21 CFR 870.2050
Device class
Class II
Review panel
Cardiovascular
Applicant
Astro-Med, Inc. 600 E. Greenwich Ave., West Warwick RI
Third party review
No

Clearances, product code DRR

Trailing 12 months

FDA records hold no clearances under product code DRR in the trailing twelve months.

FDA records show no clearances under product code DRR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260