|
Device | SUNLIGHT OMNISENSE 7000S ULTRASOUND BONE SONOMETER |
Generic Name | Bone sonometer |
Regulation Number | 892.1180 |
Applicant | BEAM-MED LTD 8 HALAPID STR. PETACH TIKVA 49170 |
PMA Number | P990035 |
Supplement Number | S003 |
Date Received | 08/10/2001 |
Decision Date | 05/24/2002 |
Reclassified Date
|
08/18/2008 |
Product Code |
MUA |
Advisory Committee |
Radiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGING THE MANUFACTURING CALIBRATION SOFTWARE BY ADDING A NEW SPECIFICATION AND TEST METHODS THAT LIMITS THE AMPLITUDES OF THE THREE DIFFERENT PROBES WHICH ARE USED FOR THE APPROVED MULTIPLE SKELETAL SITES TO LESS THAN 520MV AND NORMALIZES THE PROBES TO PREDEFINED VALUES OF APPROXIMATELY 400MV. |