510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K925346Substantially Equivalent

Ep Amp, Model #901

Quinton Electrophysiology Corp., Markham, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925346 is the FDA 510(k) clearance record for EP AMP, MODEL #901, a class II device, cleared for Quinton Electrophysiology Corp. on under FDA product code DRR (Amplifier And Signal Conditioner, Biopotential). FDA records list 3 510(k) clearances for Quinton Electrophysiology Corp., from to . As of , FDA records show no recalls naming K925346.

Clearance record

Decision date
Received
(190 days to decision)
Product code
DRR Amplifier And Signal Conditioner, Biopotential
Regulation
21 CFR 870.2050
Device class
Class II
Review panel
Cardiovascular
Applicant
Quinton Electrophysiology Corp. 3075 14th Ave., Suite 6, Markham, Ontario, CA
510(k) summary
Statement
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