BREATHE FIT— 510(k) K963326

Substantially Equivalent

Cambridge Assoc.

FDA 510(k) clearance K963326 for BREATHE FIT, Substantially Equivalent on 1997-02-12. Applicant: Cambridge Assoc.. Device class: 1.

Clearance details

Applicant: Cambridge Assoc.
Product code: Code LWF
Device class: Class 1
Regulation: 21 CFR 874.3900
Advisory panel: Ear, Nose, Throat
Date received: 1996-08-23
Decision date: 1997-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.