PMA P990035S006

Device: SUNLIGHT OMNISENSE BONE SONOMETER
Applicant: Beam-Med, Ltd.
PMA number: P990035
Supplement: S006
Product code: MUA
Decision date: 2003-04-24
Classification: Bone Sonometer
Generic name: Bone sonometer
Approval order statement: APPROVAL FOR SOFTWARE MANAGEMENT MODULE "SUNLIGHT DESKTOP" (SLD). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUNLIGHT DESKTOP, SLD AND IS AN ADD-ON TO THE OMNISENSE SOFTWARE THAT WILL FUNCTION AS AN INDEPENDENT APPLICATION. THE SUNLIGHT DESKTOP SOFTWARE ENABLES THE USER TO SHUT DOWN THE OMNISENSE SOFTWARE LEAVING THE PC SYSTEM OPERATING, SO THAT THE USER CAN THEN INITIATE ANY OTHER INSTALLED SOFTWARE (PER THE SOFTWARE MANUFACTURER REQUIREMENTS, WHICH WILL OPERATE INDEPENDENT OF THE OMNISENSE SOFTWARE. THIS WILL ALLOW THE USE OF SEVERAL DEVICES WITH THE CONTROL OF ONE PC.

Current openFDA PMA Record#

Device: SUNLIGHT OMNISENSE BONE SONOMETER
Applicant: Beam-Med, Ltd.
PMA number: P990035
Supplement: S006
Product code: MUA
Generic name: Bone sonometer
Decision date: 2003-04-24
Decision code: APPR
Date received: 2002-11-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR SOFTWARE MANAGEMENT MODULE "SUNLIGHT DESKTOP" (SLD). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUNLIGHT DESKTOP, SLD AND IS AN ADD-ON TO THE OMNISENSE SOFTWARE THAT WILL FUNCTION AS AN INDEPENDENT APPLICATION. THE SUNLIGHT DESKTOP SOFTWARE ENABLES THE USER TO SHUT DOWN THE OMNISENSE SOFTWARE LEAVING THE PC SYSTEM OPERATING, SO THAT THE USER CAN THEN INITIATE ANY OTHER INSTALLED SOFTWARE (PER THE SOFTWARE MANUFACTURER REQUIREMENTS, WHICH WILL OPERATE INDEPENDENT OF THE OMNISENSE SOFTWARE. THIS WILL ALLOW THE USE OF SEVERAL DEVICES WITH THE CONTROL OF ONE PC.