VITA-MIST AIR COMPRESSOR & NEBULIZER— 510(k) K832072

Substantially Equivalent

Vita Medics

FDA 510(k) clearance K832072 for VITA-MIST AIR COMPRESSOR & NEBULIZER, Substantially Equivalent on 1983-09-12. Applicant: Vita Medics.

Clearance details

Applicant: Vita Medics
Product code: Code BTI
Advisory panel: Anesthesiology
Date received: 1983-06-28
Decision date: 1983-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.