MODIFIED RLV-2100 B— 510(k) K864503

Name: FDA 510(k) clearance K864503
Creator: U.S. Food and Drug Administration
Published: 1987-01-06

Substantially Equivalent

American Omni Medical, Inc.

FDA 510(k) clearance K864503 for MODIFIED RLV-2100 B, Substantially Equivalent on 1987-01-06. Applicant: American Omni Medical, Inc.. Device class: 2.

Clearance details

Applicant: American Omni Medical, Inc.
Product code: Code DWD
Device class: Class 2
Regulation: 21 CFR 870.4430
Advisory panel: Cardiovascular
Date received: 1986-11-14
Decision date: 1987-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

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