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 blood pressure cuff
510(k) Number K010686
Device Name KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C
Applicant
GOLDEN HORSE MEDICAL EQUIPMENT (WUXI) CO. LTD.
1156 E. RIDGEWOOD AVE.
P.O. BOX 1211
RIDGEWOOD,  NJ  07451
Applicant Contact GARY C BAUMAN
Correspondent
ENTELA, INC.
3033 MADISON AVENUE, SE
GRAND RAPIDS,  MI  49548
Correspondent Contact N.E. DEVINE, JR.
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received03/08/2001
Decision Date 03/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
-
-