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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 the device name listed in this FDA 510(k) record. The listed applicant is Freespira, Inc.. It received FDA 510(k) clearance on 2025-04-24 under 510(k) 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. The listed applicant is Freespira, Inc.. The 510(k) number is K233337.

When did Freespira Breathing System receive FDA 510(k) clearance?

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

Who is the listed applicant for Freespira Breathing System?

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

What is the FDA product code for Freespira Breathing System?

The FDA product code for Freespira Breathing System is SEN.

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.

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