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FDA 510(k)

CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)

K-Number: K223290 · 2023-07-14

ApplicantSentiar, Inc.
Decision Date2023-07-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) is the device name listed in this FDA 510(k) record. The listed applicant is Sentiar, Inc.. It received FDA 510(k) clearance on 2023-07-14 under 510(k) number K223290. 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 CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)?

CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) is a medical device that received FDA 510(k) clearance on 2023-07-14. The listed applicant is Sentiar, Inc.. The 510(k) number is K223290.

When did CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) receive FDA 510(k) clearance?

CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) received FDA 510(k) clearance on 2023-07-14, under 510(k) number K223290.

Who is the listed applicant for CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)?

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

What is the FDA product code for CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)?

The FDA product code for CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) is LLZ.

Other records listing Sentiar, 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.

K192890SentEP

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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