FDA 510(k)

GoSpiro

K-Number: K202837 · 2020-12-04

Decision Date2020-12-04

Product CodeBZG

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

GoSpiro is the device name listed in this FDA 510(k) record. The listed applicant is Monitored Therapeutics, Inc.. It received FDA 510(k) clearance on 2020-12-04 under 510(k) number K202837. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GoSpiro?

GoSpiro is a medical device that received FDA 510(k) clearance on 2020-12-04. The listed applicant is Monitored Therapeutics, Inc.. The 510(k) number is K202837.

When did GoSpiro receive FDA 510(k) clearance?

GoSpiro received FDA 510(k) clearance on 2020-12-04, under 510(k) number K202837.

Who is the listed applicant for GoSpiro?

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

What is the FDA product code for GoSpiro?

The FDA product code for GoSpiro is BZG.

Other records listing Monitored Therapeutics, Inc. as applicant

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.

K163249GoSpiro

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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.