DURA NEB(TM) 2000 PORTABLE COMPRESSOR— 510(k) K863339

Name: FDA 510(k) clearance K863339
Creator: U.S. Food and Drug Administration
Published: 1986-10-07

Substantially Equivalent

Thera Tec, Inc.

FDA 510(k) clearance K863339 for DURA NEB(TM) 2000 PORTABLE COMPRESSOR, Substantially Equivalent on 1986-10-07. Applicant: Thera Tec, Inc.. Device class: 2.

Clearance details

Applicant: Thera Tec, Inc.
Product code: Code BTI
Device class: Class 2
Regulation: 21 CFR 868.6250
Advisory panel: Anesthesiology
Date received: 1986-08-28
Decision date: 1986-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Treasure Island, FL, US

Download summary PDF View on FDA.gov ↗

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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.