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 Device, Counter-Pulsating, External
510(k) Number K021340
Device Name AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
Applicant
External Counterpulsation Lab
85 Wu Jin Rd.
Shanghai,  CN 200080
Applicant Contact DAWEI CAI
Correspondent
External Counterpulsation Lab
85 Wu Jin Rd.
Shanghai,  CN 200080
Correspondent Contact DAWEI CAI
Regulation Number870.5225
Classification Product Code
DRN  
Date Received04/26/2002
Decision Date 01/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-