BIRD 6500 AIR COMPRESSOR— 510(k) K864547

Name: FDA 510(k) clearance K864547
Creator: U.S. Food and Drug Administration
Published: 1987-01-12

Substantially Equivalent

Bird Products Corp.

FDA 510(k) clearance K864547 for BIRD 6500 AIR COMPRESSOR, Substantially Equivalent on 1987-01-12. Applicant: Bird Products Corp.. Device class: 2.

Clearance details

Applicant: Bird Products Corp.
Product code: Code BTI
Device class: Class 2
Regulation: 21 CFR 868.6250
Advisory panel: Anesthesiology
Date received: 1986-11-19
Decision date: 1987-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Spring, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BTI

product code BTI

Death: 25
Malfunction: 1,168
Total: 1,193

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.