• 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 recorder, magnetic tape, medical
510(k) Number K163535
Device Name my Patch sl
Applicant
DMS-SERVICE LLC
11845 W OLYMPIC BLVD
STE 880W
LOS ANGELES,  CA  90064
Applicant Contact LYNDA COLE
Correspondent
DMS-SERVICE LLC
11845 W OLYMPIC BLVD
STE 880W
LOS ANGELES,  CA  90064
Correspondent Contact LYNDA COLE
Regulation Number870.2800
Classification Product Code
DSH  
Date Received12/16/2016
Decision Date 02/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-