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

Name: FDA 510(k) clearance K832072
Creator: U.S. Food and Drug Administration
Published: 1983-09-12

Substantially Equivalent

Vita Medics

FDA 510(k) clearance K832072 for VITA-MIST AIR COMPRESSOR & NEBULIZER, Substantially Equivalent on 1983-09-12. Applicant: Vita Medics. Device class: 2.

Clearance details

Applicant: Vita Medics
Product code: Code BTI
Device class: Class 2
Regulation: 21 CFR 868.6250
Advisory panel: Anesthesiology
Date received: 1983-06-28
Decision date: 1983-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BTI

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K131881 — OMBRA TABLE TOP COMPRESSOR2013-10-24
K113338 — MEDICAL AIR COMPRESSOR2012-08-10
K091871 — DK50 DS2009-10-23
K072634 — EMG TRITON -COMP,MODEL NCA01-XXX SERIES2008-11-19
K060781 — MEDICAL COMPRESSOR, MODELS DK50 D AND DM2006-10-03

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.