510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911935Substantially Equivalent

Cardiac Electrophysical Lead Selector, Modified

Gould, Inc., Valley View OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911935 is the FDA 510(k) clearance record for CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED, a class II device, cleared for Gould, Inc. on under FDA product code DRR (Amplifier And Signal Conditioner, Biopotential). FDA records list one 510(k) clearance for Gould, Inc. As of , FDA records show no recalls naming K911935.

Clearance record

Decision date
Received
(82 days to decision)
Product code
DRR Amplifier And Signal Conditioner, Biopotential
Regulation
21 CFR 870.2050
Device class
Class II
Review panel
Cardiovascular
Applicant
Gould, Inc. 8333 Rockside Rd., Valley View OH
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