SUNLIGHT OMNISENSE 7000S ULTRASOUND BONE SONOMETER

Bone Sonometer

FDA Premarket Approval P990035 S003

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.

Pre-market Approval Supplement Details

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.

• Device: SUNLIGHT OMNISENSE 7000S ULTRASOUND BONE SONOMETER
• Classification Name: Bone Sonometer
• Generic Name: Bone Sonometer
• Applicant: BEAM-MED LTD
• Date Received: 2001-08-10
• Decision Date: 2002-05-24
• PMA: P990035
• Supplement: S003
• Product Code: MUA
• Advisory Committee: Radiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: BEAM-MED LTD 8 Halapid Str. petach Tikva 49170

Supplemental Filings

Supplement Number	Date	Supplement Type
P990035		Original Filing
S006	2002-11-01	Normal 180 Day Track
S005	2001-12-21	Normal 180 Day Track
S004	2001-09-25	Normal 180 Day Track
S003	2001-08-10	Normal 180 Day Track
S002	2001-06-26	Normal 180 Day Track
S001	2000-06-26	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
07299012704119	P990035	000