BUBBLE TRAP-FILTER CAT. NO B180F37— 510(k) K873316

Name: FDA 510(k) clearance K873316
Creator: U.S. Food and Drug Administration
Published: 1988-07-14

Substantially Equivalent

American Omni Medical, Inc.

FDA 510(k) clearance K873316 for BUBBLE TRAP-FILTER CAT. NO B180F37, Substantially Equivalent on 1988-07-14. Applicant: American Omni Medical, Inc.. Device class: 2.

Clearance details

Applicant: American Omni Medical, Inc.
Product code: Code DTM
Device class: Class 2
Regulation: 21 CFR 870.4260
Advisory panel: Cardiovascular
Date received: 1987-08-19
Decision date: 1988-07-14
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.