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 System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K010392
Device Name ATHENA REMOTE CONTROLLED RF SYSTEM
Applicant
Cares Built, Inc.
75 Manchester Ave.
Keyport,  NJ  07735
Applicant Contact TIMOTHY TELYMONDE
Correspondent
Cares Built, Inc.
75 Manchester Ave.
Keyport,  NJ  07735
Correspondent Contact TIMOTHY TELYMONDE
Regulation Number892.1650
Classification Product Code
JAA  
Date Received02/08/2001
Decision Date 03/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-