Somnera System— 510(k) K200698
Substantially EquivalentFresca Medical, Inc.
FDA 510(k) clearance K200698 for Somnera System, Substantially Equivalent on 2020-06-29. Applicant: Fresca Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Fresca Medical, Inc.
- Product code
- Code QBY
- Device class
- Class 2
- Regulation
- 21 CFR 868.5273
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Clemente, CA, US
Recent devices under product code QBY
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