LIFECARE NASAL MASK KIT CAT. NO. 06-800— 510(k) K894779

Name: FDA 510(k) clearance K894779
Creator: U.S. Food and Drug Administration
Published: 1990-01-12

Substantially Equivalent

Lifecare Services, Inc.

FDA 510(k) clearance K894779 for LIFECARE NASAL MASK KIT CAT. NO. 06-800, Substantially Equivalent on 1990-01-12. Applicant: Lifecare Services, Inc.. Device class: 2.

Clearance details

Applicant: Lifecare Services, Inc.
Product code: Code BYE
Device class: Class 2
Regulation: 21 CFR 868.5965
Advisory panel: Anesthesiology
Date received: 1989-07-27
Decision date: 1990-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lafayette, CO, US

Download summary PDF View on FDA.gov ↗

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K913423 — LIFECARE REMOTE ALARM II1992-01-30
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K910947 — NEV-10 NEGATIVE PRESSURE VENTILATOR1991-06-03
K895592 — FREEWAY NEBULIZER COMPRESSOR1989-11-21
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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.