SpiroHome Personal, SpiroHome Clinic
K-Number: K213754 · 2023-06-12
ApplicantInofab Saglik Teknolojileri A.S
Decision Date2023-06-12
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
SpiroHome Personal, SpiroHome Clinic is a medical device manufactured by Inofab Saglik Teknolojileri A.S. It received FDA 510(k) clearance on 2023-06-12 under approval number K213754. 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 SpiroHome Personal, SpiroHome Clinic?
SpiroHome Personal, SpiroHome Clinic is a medical device that received FDA 510(k) clearance on 2023-06-12. It is manufactured by Inofab Saglik Teknolojileri A.S. The 510(k) number is K213754.
When was SpiroHome Personal, SpiroHome Clinic approved by the FDA?
SpiroHome Personal, SpiroHome Clinic received FDA 510(k) clearance on 2023-06-12, under approval number K213754.
What company makes SpiroHome Personal, SpiroHome Clinic?
SpiroHome Personal, SpiroHome Clinic is manufactured by Inofab Saglik Teknolojileri A.S.
What is the FDA product code for SpiroHome Personal, SpiroHome Clinic?
The FDA product code for SpiroHome Personal, SpiroHome Clinic is BZG.
Related Clinical Trials
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.