NEV-10 NEGATIVE PRESSURE VENTILATOR— 510(k) K910947

Name: FDA 510(k) clearance K910947
Creator: U.S. Food and Drug Administration
Published: 1991-06-03

Substantially Equivalent

Lifecare Services, Inc.

FDA 510(k) clearance K910947 for NEV-10 NEGATIVE PRESSURE VENTILATOR, Substantially Equivalent on 1991-06-03. Applicant: Lifecare Services, Inc.. Device class: 2.

Clearance details

Applicant: Lifecare Services, Inc.
Product code: Code BYT
Device class: Class 2
Regulation: 21 CFR 868.5935
Advisory panel: Anesthesiology
Date received: 1991-03-06
Decision date: 1991-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lafayette, CO, US

Download summary PDF View on FDA.gov ↗

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