PMA P990035S003

Device: SUNLIGHT OMNISENSE 7000S ULTRASOUND BONE SONOMETER
Applicant: Beam-Med, Ltd.
PMA number: P990035
Supplement: S003
Product code: MUA
Decision date: 2002-05-24
Classification: Bone Sonometer
Generic name: Bone sonometer
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.

Current openFDA PMA Record#

Device: SUNLIGHT OMNISENSE 7000S ULTRASOUND BONE SONOMETER
Applicant: Beam-Med, Ltd.
PMA number: P990035
Supplement: S003
Product code: MUA
Generic name: Bone sonometer
Decision date: 2002-05-24
Decision code: APPR
Date received: 2001-08-10
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.