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 Sleeve, Limb, Compressible
510(k) Number K122873
Device Name VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS
Applicant
Caremed Supply, Inc.
7f, #2, Lane 235, Bao Chiao Rd.
New Taipei City
Taipei Xen District,  CN 23145
Applicant Contact MICHAEL LEE
Correspondent
Caremed Supply, Inc.
7f, #2, Lane 235, Bao Chiao Rd.
New Taipei City
Taipei Xen District,  CN 23145
Correspondent Contact MICHAEL LEE
Regulation Number870.5800
Classification Product Code
JOW  
Date Received09/19/2012
Decision Date 01/15/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-