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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 a medical device manufactured by Ortho2, LLC. It received FDA 510(k) clearance on 2019-10-17 under approval 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. It is manufactured by Ortho2, LLC. The 510(k) number is K190162.

When was SmartCeph approved by the FDA?

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

What company makes SmartCeph?

SmartCeph is manufactured by Ortho2, LLC.

What is the FDA product code for SmartCeph?

The FDA product code for SmartCeph is LLZ.

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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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