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FDA 510(k)

NOVATECH TALCAIR

K-Number: K151832 · 2016-03-31

ApplicantNovatech SA
Decision Date2016-03-31
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NOVATECH TALCAIR is the device name listed in this FDA 510(k) record. The listed applicant is Novatech SA. It received FDA 510(k) clearance on 2016-03-31 under 510(k) number K151832. 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 2016-03-31. The listed applicant is Novatech SA. The 510(k) number is K151832.

When did NOVATECH TALCAIR receive FDA 510(k) clearance?

NOVATECH TALCAIR received FDA 510(k) clearance on 2016-03-31, under 510(k) number K151832.

Who is the listed applicant for NOVATECH TALCAIR?

The FDA 510(k) record lists Novatech SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NOVATECH TALCAIR?

The FDA product code for NOVATECH TALCAIR is GCJ.

Other records listing Novatech SA 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.

K242324DUTAU-NOVATECH®K243126TRACHEOBRONXANE™ DUMON®K170030NOVATECH TALCAIR

Related Devices (Code: GCJ)

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.

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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.

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