TOTAL LUNG EXERCISER (TLE)— 510(k) K871904

Name: FDA 510(k) clearance K871904
Creator: U.S. Food and Drug Administration
Published: 1987-07-08

Substantially Equivalent

MBA Healthcare Products, Inc.

FDA 510(k) clearance K871904 for TOTAL LUNG EXERCISER (TLE), Substantially Equivalent on 1987-07-08. Applicant: MBA Healthcare Products, Inc.. Device class: 2.

Clearance details

Applicant: MBA Healthcare Products, Inc.
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 1987-05-15
Decision date: 1987-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fayetteville, NY, US

Download summary PDF View on FDA.gov ↗

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