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FDA 510(k)

Cliniview

K-Number: K162799 · 2017-04-25

ApplicantPalodex Group OY
Decision Date2017-04-25
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Cliniview is the device name listed in this FDA 510(k) record. The listed applicant is Palodex Group OY. It received FDA 510(k) clearance on 2017-04-25 under 510(k) number K162799. 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 Cliniview?

Cliniview is a medical device that received FDA 510(k) clearance on 2017-04-25. The listed applicant is Palodex Group OY. The 510(k) number is K162799.

When did Cliniview receive FDA 510(k) clearance?

Cliniview received FDA 510(k) clearance on 2017-04-25, under 510(k) number K162799.

Who is the listed applicant for Cliniview?

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

What is the FDA product code for Cliniview?

The FDA product code for Cliniview is LLZ.

Other records listing Palodex Group OY as applicant

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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, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

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.

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