AVA-MIST PORTABLE AIR COMPRESSOR— 510(k) K844956

Substantially Equivalent

Avatron, Inc.

FDA 510(k) clearance K844956 for AVA-MIST PORTABLE AIR COMPRESSOR, Substantially Equivalent on 1985-02-14. Applicant: Avatron, Inc..

Clearance details

Applicant: Avatron, Inc.
Product code: Code BTI
Advisory panel: Anesthesiology
Date received: 1984-12-21
Decision date: 1985-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Benicia, CA, US

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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.