PERSONAL WHEEZOMETER— 510(k) K090863

Substantially Equivalent

Karmelsonix

FDA 510(k) clearance K090863 for PERSONAL WHEEZOMETER, Substantially Equivalent on 2009-09-21. Applicant: Karmelsonix. Device class: 2.

Clearance details

Applicant: Karmelsonix
Product code: Code BZM
Device class: Class 2
Regulation: 21 CFR 868.1900
Advisory panel: Anesthesiology
Date received: 2009-03-30
Decision date: 2009-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Binyamina, IL

Download summary PDF View on FDA.gov ↗

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