MISTASSIST BREATHING EXERCISER— 510(k) K953055

Name: FDA 510(k) clearance K953055
Creator: U.S. Food and Drug Administration
Published: 1996-02-08

Substantially Equivalent

The Merlin Corp.

FDA 510(k) clearance K953055 for MISTASSIST BREATHING EXERCISER, Substantially Equivalent on 1996-02-08. Applicant: The Merlin Corp.. Device class: 2.

Clearance details

Applicant: The Merlin Corp.
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 1995-06-30
Decision date: 1996-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camarillo, CA, US

Download summary PDF View on FDA.gov ↗

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