BARD(R) BIOPOTENTIAL AMPLIFIER II— 510(k) K913875

Name: FDA 510(k) clearance K913875
Creator: U.S. Food and Drug Administration
Published: 1991-11-27

Substantially Equivalent

Bard Electrophysiology

FDA 510(k) clearance K913875 for BARD(R) BIOPOTENTIAL AMPLIFIER II, Substantially Equivalent on 1991-11-27. Applicant: Bard Electrophysiology. Device class: 2.

Clearance details

Applicant: Bard Electrophysiology
Product code: Code DRQ
Device class: Class 2
Regulation: 21 CFR 870.2060
Advisory panel: Cardiovascular
Date received: 1991-08-29
Decision date: 1991-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tewksbury, MA, US

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