FDA 510(k)

CephSimulation

K-Number: K161270 · 2017-01-04

Decision Date2017-01-04

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CephSimulation is the device name listed in this FDA 510(k) record. The listed applicant is Anatomage, Inc.. It received FDA 510(k) clearance on 2017-01-04 under 510(k) number K161270. 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 CephSimulation?

CephSimulation is a medical device that received FDA 510(k) clearance on 2017-01-04. The listed applicant is Anatomage, Inc.. The 510(k) number is K161270.

When did CephSimulation receive FDA 510(k) clearance?

CephSimulation received FDA 510(k) clearance on 2017-01-04, under 510(k) number K161270.

Who is the listed applicant for CephSimulation?

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

What is the FDA product code for CephSimulation?

The FDA product code for CephSimulation is LLZ.

Other records listing Anatomage, Inc. 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.

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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.