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)

Spirotrac

K-Number: K201562 · 2020-10-14

ApplicantVitalograph Ireland, Ltd.
Decision Date2020-10-14
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Spirotrac is a medical device manufactured by Vitalograph Ireland, Ltd.. It received FDA 510(k) clearance on 2020-10-14 under approval number K201562. 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 Spirotrac?

Spirotrac is a medical device that received FDA 510(k) clearance on 2020-10-14. It is manufactured by Vitalograph Ireland, Ltd.. The 510(k) number is K201562.

When was Spirotrac approved by the FDA?

Spirotrac received FDA 510(k) clearance on 2020-10-14, under approval number K201562.

What company makes Spirotrac?

Spirotrac is manufactured by Vitalograph Ireland, Ltd..

What is the FDA product code for Spirotrac?

The FDA product code for Spirotrac is BZG.

Other Devices by Vitalograph Ireland, Ltd.

K200550Vitalograph Model 2120 In2itive eDiary K221030Model 9100 PFT/DICO K212938Vitalograph Model 6000 Alpha K223818Model 9160 VitaloQUB

Related Devices (Code: BZG)

K161676Q13 SPIROLYSER®Fim Medical K160116SpiroScoutGanshorn Medizin Electronic GmbH K160253Vitalograph Model 6300 microVitalograph (Ireland) , Ltd. K150515IQSense Flow Sensor MouthpieceSdi Diagnostics, Inc. K163249GoSpiroMonitored Therapeutics, Inc. K161536EasyOne Air SpirometerNdd Medizintechnik AG

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.

↑