BODAI NEO2 -SAFE AIRWAY PRESSURE CAP— 510(k) K913753

Name: FDA 510(k) clearance K913753
Creator: U.S. Food and Drug Administration
Published: 1991-10-23

Substantially Equivalent

B&B Medical Technologies, Inc.

FDA 510(k) clearance K913753 for BODAI NEO2 -SAFE AIRWAY PRESSURE CAP, Substantially Equivalent on 1991-10-23. Applicant: B&B Medical Technologies, Inc.. Device class: 1.

Clearance details

Applicant: B&B Medical Technologies, Inc.
Product code: Code CAI
Device class: Class 1
Regulation: 21 CFR 868.5240
Advisory panel: Anesthesiology
Date received: 1991-08-21
Decision date: 1991-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orangevale, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CAI

product code CAI

Malfunction: 869
Other: 1
Total: 870

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.