Makani Science Respiration Monitoring System— 510(k) K233953
Substantially EquivalentMakani Science, Inc.
FDA 510(k) clearance K233953 for Makani Science Respiration Monitoring System, Substantially Equivalent on 2025-03-28. Applicant: Makani Science, Inc.. Device class: 2.
Clearance details
- Applicant
- Makani Science, Inc.
- Product code
- Code BZQ
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code BZQ
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