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FDA 510(k)

Makani Science™ Respiration Monitoring System

K-Number: K233953 · 2025-03-28

ApplicantMakani Science, Inc.
Decision Date2025-03-28
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Makani Science™ Respiration Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Makani Science, Inc.. It received FDA 510(k) clearance on 2025-03-28 under 510(k) 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. The listed applicant is Makani Science, Inc.. The 510(k) number is K233953.

When did Makani Science™ Respiration Monitoring System receive FDA 510(k) clearance?

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

Who is the listed applicant for Makani Science™ Respiration Monitoring System?

The FDA 510(k) record lists Makani Science, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06000852Comparison of Non-Invasive Respiratory Monitoring System (RMS)COMPLETED

Related Devices (Code: BZQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253274BedDot (G1)Intelligent Dots, LLCK251326Respiration Rate algorithmEdwards Lifesciences, LLCK250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLCK243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.

Official Source

View on FDA Database →

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

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