FDA 510(k)

Terran NM-101

K-Number: K230187 · 2023-09-29

Decision Date2023-09-29

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Terran NM-101 is the device name listed in this FDA 510(k) record. The listed applicant is Terran Biosciences, Inc.. It received FDA 510(k) clearance on 2023-09-29 under 510(k) number K230187. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Terran NM-101?

Terran NM-101 is a medical device that received FDA 510(k) clearance on 2023-09-29. The listed applicant is Terran Biosciences, Inc.. The 510(k) number is K230187.

When did Terran NM-101 receive FDA 510(k) clearance?

Terran NM-101 received FDA 510(k) clearance on 2023-09-29, under 510(k) number K230187.

Who is the listed applicant for Terran NM-101?

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

What is the FDA product code for Terran NM-101?

The FDA product code for Terran NM-101 is LNH.

Related Devices (Code: LNH)

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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.