PEDIATRIC BUBBLE TRAP CAT. NO. B-100— 510(k) K873610

Name: FDA 510(k) clearance K873610
Creator: U.S. Food and Drug Administration
Published: 1987-11-05

Substantially Equivalent

American Omni Medical, Inc.

FDA 510(k) clearance K873610 for PEDIATRIC BUBBLE TRAP CAT. NO. B-100, Substantially Equivalent on 1987-11-05. Applicant: American Omni Medical, Inc.. Device class: 1.

Clearance details

Applicant: American Omni Medical, Inc.
Product code: Code BSY
Device class: Class 1
Regulation: 21 CFR 868.6810
Advisory panel: Anesthesiology
Date received: 1987-09-08
Decision date: 1987-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BSY

product code BSY

Death: 3
Injury: 155
Malfunction: 959
Total: 1,117

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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