Peak.me— 510(k) K180487
Substantially EquivalentBreathe Me, Ltd.
FDA 510(k) clearance K180487 for Peak.me, Substantially Equivalent on 2018-10-26. Applicant: Breathe Me, Ltd.. Device class: 2.
Clearance details
- Applicant
- Breathe Me, Ltd.
- Product code
- Code BZH
- Device class
- Class 2
- Regulation
- 21 CFR 868.1860
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ra'Anana, IL
Recent devices under product code BZH
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