Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K230187
Device Name Terran NM-101
Applicant
Terran Biosciences, Inc.
507 W. 28th St. Ph 3a
New York,  NY  10001
Applicant Contact Sam Clark
Correspondent
Medical Device Regulatory Solutions, LLC
230 Collingwood Dr., Suite 260
Ann Arbor,  MI  48103
Correspondent Contact Kay Fuller
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
LLZ  
Date Received01/23/2023
Decision Date 09/29/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-