• 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 electrocardiograph, ambulatory (without analysis)
510(k) Number K161062
Device Name NR Recorder
Applicant
Norav Medical GmbH
Otto von Guericke Ring 10
Wiesbaden,  DE 65205
Applicant Contact David Seal
Correspondent
Licensale Inc
57 Lazy Brook Rd
Monroe,  CT  06468
Correspondent Contact Raymond Kelly
Regulation Number870.2800
Classification Product Code
MWJ  
Date Received04/15/2016
Decision Date 06/13/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-