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FDA 510(k)

Freespira Breathing System

K-Number: K233337 · 2025-04-24

ApplicantFreespira, Inc.
Decision Date2025-04-24
Product CodeSEN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Freespira Breathing System is a medical device manufactured by Freespira, Inc.. It received FDA 510(k) clearance on 2025-04-24 under approval number K233337. The device is classified under product code SEN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Freespira Breathing System?

Freespira Breathing System is a medical device that received FDA 510(k) clearance on 2025-04-24. It is manufactured by Freespira, Inc.. The 510(k) number is K233337.

When was Freespira Breathing System approved by the FDA?

Freespira Breathing System received FDA 510(k) clearance on 2025-04-24, under approval number K233337.

What company makes Freespira Breathing System?

Freespira Breathing System is manufactured by Freespira, Inc..

What is the FDA product code for Freespira Breathing System?

The FDA product code for Freespira Breathing System is SEN.

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Official Source

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