Decision Date1990-05-09
Product CodeDRQ
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
BARD BIOPOTENTIAL AMPLIFIER II is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 1990-05-09 under 510(k) number K901358. The device is classified under product code DRQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BARD BIOPOTENTIAL AMPLIFIER II?
BARD BIOPOTENTIAL AMPLIFIER II is a medical device that received FDA 510(k) clearance on 1990-05-09. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K901358.
When did BARD BIOPOTENTIAL AMPLIFIER II receive FDA 510(k) clearance?
BARD BIOPOTENTIAL AMPLIFIER II received FDA 510(k) clearance on 1990-05-09, under 510(k) number K901358.
Who is the listed applicant for BARD BIOPOTENTIAL AMPLIFIER II?
The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BARD BIOPOTENTIAL AMPLIFIER II?
The FDA product code for BARD BIOPOTENTIAL AMPLIFIER II is DRQ.
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Official Source
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