Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GoSpiro

K-Number: K163249 · 2017-03-24

ApplicantMonitored Therapeutics, Inc.
Decision Date2017-03-24
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GoSpiro is a medical device manufactured by Monitored Therapeutics, Inc.. It received FDA 510(k) clearance on 2017-03-24 under approval number K163249. 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 2017-03-24. It is manufactured by Monitored Therapeutics, Inc.. The 510(k) number is K163249.

When was GoSpiro approved by the FDA?

GoSpiro received FDA 510(k) clearance on 2017-03-24, under approval number K163249.

What company makes GoSpiro?

GoSpiro is manufactured by Monitored Therapeutics, Inc..

What is the FDA product code for GoSpiro?

The FDA product code for GoSpiro is BZG.

Other Devices by Monitored Therapeutics, Inc.

K202837GoSpiro

Related Devices (Code: BZG)

K161676Q13 SPIROLYSER®Fim Medical K160116SpiroScoutGanshorn Medizin Electronic GmbH K160253Vitalograph Model 6300 microVitalograph (Ireland) , Ltd. K150515IQSense Flow Sensor MouthpieceSdi Diagnostics, Inc. K161536EasyOne Air SpirometerNdd Medizintechnik AG K180011Pulmonx Chartis Tablet ConsolePulmonx Corporation

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.

↑