FDA 510(k)

nCommand Lite System

K-Number: K233660 · 2024-03-18

Decision Date2024-03-18

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

nCommand Lite System is the device name listed in this FDA 510(k) record. The listed applicant is Ionic Health. It received FDA 510(k) clearance on 2024-03-18 under 510(k) number K233660. 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 nCommand Lite System?

nCommand Lite System is a medical device that received FDA 510(k) clearance on 2024-03-18. The listed applicant is Ionic Health. The 510(k) number is K233660.

When did nCommand Lite System receive FDA 510(k) clearance?

nCommand Lite System received FDA 510(k) clearance on 2024-03-18, under 510(k) number K233660.

Who is the listed applicant for nCommand Lite System?

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

What is the FDA product code for nCommand Lite System?

The FDA product code for nCommand Lite System 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.

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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.