FDA 510(k)

Makani Science Respiration Monitoring System

K-Number: K233953 · 2025-03-28

Decision Date2025-03-28

Product CodeBZQ

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Makani Science Respiration Monitoring System is a medical device manufactured by Makani Science, Inc.. It received FDA 510(k) clearance on 2025-03-28 under approval number K233953. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Makani Science Respiration Monitoring System?

Makani Science Respiration Monitoring System is a medical device that received FDA 510(k) clearance on 2025-03-28. It is manufactured by Makani Science, Inc.. The 510(k) number is K233953.

When was Makani Science Respiration Monitoring System approved by the FDA?

Makani Science Respiration Monitoring System received FDA 510(k) clearance on 2025-03-28, under approval number K233953.

What company makes Makani Science Respiration Monitoring System?

Makani Science Respiration Monitoring System is manufactured by Makani Science, Inc..

What is the FDA product code for Makani Science Respiration Monitoring System?

The FDA product code for Makani Science Respiration Monitoring System is BZQ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.