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, imaging, pulsed echo, ultrasonic
510(k) Number K042250
Device Name SENSATOUCH
Applicant
ALUNA MANAGEMENT CO., LTD.
4859 MARTIN CT.
SUITE #5
SMYRNA,  GA  30082
Applicant Contact CHARITY MARTIN
Correspondent
ALUNA MANAGEMENT CO., LTD.
4859 MARTIN CT.
SUITE #5
SMYRNA,  GA  30082
Correspondent Contact CHARITY MARTIN
Regulation Number892.1560
Classification Product Code
IYO  
Date Received08/20/2004
Decision Date 11/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-