TURBO AIR COMPRESSOR 8000— 510(k) K883829

Name: FDA 510(k) clearance K883829
Creator: U.S. Food and Drug Administration
Published: 1989-03-23

Substantially Equivalent

Necon Medical, Inc.

FDA 510(k) clearance K883829 for TURBO AIR COMPRESSOR 8000, Substantially Equivalent on 1989-03-23. Applicant: Necon Medical, Inc.. Device class: 2.

Clearance details

Applicant: Necon Medical, Inc.
Product code: Code BTI
Device class: Class 2
Regulation: 21 CFR 868.6250
Advisory panel: Anesthesiology
Date received: 1988-09-09
Decision date: 1989-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon, CT, 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.