Makani Science Respiration Monitoring System— 510(k) K233953

Substantially Equivalent

Makani Science, Inc.

FDA 510(k) clearance K233953 for Makani Science Respiration Monitoring System, Substantially Equivalent on 2025-03-28. Applicant: Makani Science, Inc..

Clearance details

Applicant: Makani Science, Inc.
Product code: Code BZQ
Advisory panel: Anesthesiology
Date received: 2023-12-15
Decision date: 2025-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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