NOVATECH TALCAIR
K-Number: K170030 · 2017-03-13
ApplicantNovatech SA
Decision Date2017-03-13
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
NOVATECH TALCAIR is a medical device manufactured by Novatech SA. It received FDA 510(k) clearance on 2017-03-13 under approval number K170030. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NOVATECH TALCAIR?
NOVATECH TALCAIR is a medical device that received FDA 510(k) clearance on 2017-03-13. It is manufactured by Novatech SA. The 510(k) number is K170030.
When was NOVATECH TALCAIR approved by the FDA?
NOVATECH TALCAIR received FDA 510(k) clearance on 2017-03-13, under approval number K170030.
What company makes NOVATECH TALCAIR?
NOVATECH TALCAIR is manufactured by Novatech SA.
What is the FDA product code for NOVATECH TALCAIR?
The FDA product code for NOVATECH TALCAIR is GCJ.
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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.