• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • 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
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSUNLIGHT OMNISENSE ULTRASOUND BONE SONOMETER
Classification Namebone sonometer
Generic Namebone sonometer
Regulation Number892.1180
Applicant
BEAM-MED LTD
8 halapid str.
petach tikva 49170
PMA NumberP990035
Supplement NumberS002
Date Received06/26/2001
Decision Date07/27/2001
Product Code
MUA[ Registered Establishments with MUA ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT SUNLIGHT MEDICAL LTD., TEL-AVIV, ISRAEL.
-
-