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 Compressor, Cardiac, External
510(k) Number K011046
Device Name AUTOPULSE, MODEL 100
Applicant
Revivant Corp.
775 Palomar
Sunnyvale,  CA  94085
Applicant Contact BOB KATZ
Correspondent
Revivant Corp.
775 Palomar
Sunnyvale,  CA  94085
Correspondent Contact BOB KATZ
Regulation Number870.5200
Classification Product Code
DRM  
Date Received04/06/2001
Decision Date 10/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-