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FDA 510(k)

SmartCeph

K-Number: K190162 · 2019-10-17

ApplicantOrtho2, LLC
Decision Date2019-10-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SmartCeph is the device name listed in this FDA 510(k) record. The listed applicant is Ortho2, LLC. It received FDA 510(k) clearance on 2019-10-17 under 510(k) number K190162. 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 SmartCeph?

SmartCeph is a medical device that received FDA 510(k) clearance on 2019-10-17. The listed applicant is Ortho2, LLC. The 510(k) number is K190162.

When did SmartCeph receive FDA 510(k) clearance?

SmartCeph received FDA 510(k) clearance on 2019-10-17, under 510(k) number K190162.

Who is the listed applicant for SmartCeph?

The FDA 510(k) record lists Ortho2, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmartCeph?

The FDA product code for SmartCeph 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, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid 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.

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