FDA 510(k)

SUITESTENSA

K-Number: K163668 · 2017-06-23

Decision Date2017-06-23

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SUITESTENSA is the device name listed in this FDA 510(k) record. The listed applicant is Ebit Srl. It received FDA 510(k) clearance on 2017-06-23 under 510(k) number K163668. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUITESTENSA?

SUITESTENSA is a medical device that received FDA 510(k) clearance on 2017-06-23. The listed applicant is Ebit Srl. The 510(k) number is K163668.

When did SUITESTENSA receive FDA 510(k) clearance?

SUITESTENSA received FDA 510(k) clearance on 2017-06-23, under 510(k) number K163668.

Who is the listed applicant for SUITESTENSA?

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

What is the FDA product code for SUITESTENSA?

The FDA product code for SUITESTENSA is LLZ.

Related Devices (Code: LLZ)

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLC K261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation K262143ImageGrid StreamVueCandelis, Inc.

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.