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FDA 510(k)

Terran NM-101

K-Number: K230187 · 2023-09-29

ApplicantTerran Biosciences, Inc.
Decision Date2023-09-29
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Terran NM-101 is a medical device manufactured by Terran Biosciences, Inc.. It received FDA 510(k) clearance on 2023-09-29 under approval 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. It is manufactured by Terran Biosciences, Inc.. The 510(k) number is K230187.

When was Terran NM-101 approved by the FDA?

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

What company makes Terran NM-101?

Terran NM-101 is manufactured by Terran Biosciences, Inc..

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

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

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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.

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