Breathe+— 510(k) K222018
Substantially EquivalentPeep Medical, LLC Dba Go2 Devices
FDA 510(k) clearance K222018 for Breathe+, Substantially Equivalent on 2023-06-02. Applicant: Peep Medical, LLC Dba Go2 Devices. Device class: 2.
Clearance details
- Applicant
- Peep Medical, LLC Dba Go2 Devices
- Product code
- Code BWF
- Device class
- Class 2
- Regulation
- 21 CFR 868.5690
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, US
Recent devices under product code BWF
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