DEVILBISS MODEL 7351 SERIES— 510(k) K894424

Name: FDA 510(k) clearance K894424
Creator: U.S. Food and Drug Administration
Published: 1989-09-18

Substantially Equivalent

Devilbiss Health Care, Inc.

FDA 510(k) clearance K894424 for DEVILBISS MODEL 7351 SERIES, Substantially Equivalent on 1989-09-18. Applicant: Devilbiss Health Care, Inc.. Device class: 2.

Clearance details

Applicant: Devilbiss Health Care, Inc.
Product code: Code BYE
Device class: Class 2
Regulation: 21 CFR 868.5965
Advisory panel: Anesthesiology
Date received: 1989-07-17
Decision date: 1989-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BYE

view all

K160112 — Besmed PEEP Valve2016-04-29
K133957 — DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE2014-04-14
K133210 — B&B BUBBLER2014-03-28
K122610 — PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES2013-08-05
K112546 — O_TWO CPAP SYSTEM2011-12-27

More clearances from Devilbiss Health Care, Inc.

view all

K963349 — DEVILBISS 8650D1997-06-13
K970289 — COMPRESSOR/NEBULIZER #36501997-04-15
K961126 — PULSE DOSE SERIES1996-10-21
K950849 — MODEL #73541996-02-08
K952491 — MODEL 73551996-01-31

Adverse events under product code BYE

product code BYE

Death: 5
Total: 5

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.