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 a medical device manufactured by Sentiar, Inc.. It received FDA 510(k) clearance on 2023-07-14 under approval 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. It is manufactured by Sentiar, Inc.. The 510(k) number is K223290.
When was CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) approved by the FDA?
CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) received FDA 510(k) clearance on 2023-07-14, under approval number K223290.
What company makes CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)?
CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) is manufactured by Sentiar, Inc..
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 Devices by Sentiar, Inc.
Related Devices (Code: LLZ)
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.