Peak.me— 510(k) K180487

Substantially Equivalent

Breathe Me, Ltd.

FDA 510(k) clearance K180487 for Peak.me, Substantially Equivalent on 2018-10-26. Applicant: Breathe Me, Ltd..

Clearance details

Applicant: Breathe Me, Ltd.
Product code: Code BZH
Advisory panel: Anesthesiology
Date received: 2018-02-23
Decision date: 2018-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ra'Anana, IL

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