510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K901358Substantially Equivalent

Bard Biopotential Amplifier II

C.R. Bard Inc, Billerica MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901358 is the FDA 510(k) clearance record for BARD BIOPOTENTIAL AMPLIFIER II, a class II device, cleared for C.R. Bard, Inc. on under FDA product code DRQ (Amplifier And Signal Conditioner, Transducer Signal). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K901358.

Clearance record

Decision date
Received
(47 days to decision)
Product code
DRQ Amplifier And Signal Conditioner, Transducer Signal
Regulation
21 CFR 870.2060
Device class
Class II
Review panel
Cardiovascular
Applicant
C.R. Bard, Inc. 5 Federal St., Billerica MA
Third party review
No

Clearances, product code DRQ

Trailing 12 months

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

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