CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700— 510(k) K884640

Name: FDA 510(k) clearance K884640
Creator: U.S. Food and Drug Administration
Published: 1989-01-24

Substantially Equivalent

American Omni Medical, Inc.

FDA 510(k) clearance K884640 for CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700, Substantially Equivalent on 1989-01-24. Applicant: American Omni Medical, Inc.. Device class: 1.

Clearance details

Applicant: American Omni Medical, Inc.
Product code: Code KRI
Device class: Class 1
Regulation: 21 CFR 870.4200
Advisory panel: Cardiovascular
Date received: 1988-11-07
Decision date: 1989-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.