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510(k) K230187

Terran NM-101 by Terran Biosciences, Inc. — Product Code LNH

K230187 is an FDA 510(k) premarket notification submitted by Terran Biosciences, Inc. for the device "Terran NM-101". The FDA issued a decision of Substantially Equivalent on September 29, 2023. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2023
Date Received
January 23, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nuclear Magnetic Resonance Imaging
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

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FDA data resources