DEVILBISS 8650D— 510(k) K963349

Name: FDA 510(k) clearance K963349
Creator: U.S. Food and Drug Administration
Published: 1997-06-13

Substantially Equivalent

Devilbiss Health Care, Inc.

FDA 510(k) clearance K963349 for DEVILBISS 8650D, Substantially Equivalent on 1997-06-13. Applicant: Devilbiss Health Care, Inc.. Device class: 2.

Clearance details

Applicant: Devilbiss Health Care, Inc.
Product code: Code BTI
Device class: Class 2
Regulation: 21 CFR 868.6250
Advisory panel: Anesthesiology
Date received: 1996-08-26
Decision date: 1997-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset, PA, US

Download summary PDF View on FDA.gov ↗

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K970289 — COMPRESSOR/NEBULIZER #36501997-04-15
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K950849 — MODEL #73541996-02-08
K952491 — MODEL 73551996-01-31
K952249 — JET NEBULIZER1996-01-30

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.