SUNLIGHT OMNISENSE BONE SONOMETER
FDA premarket approval P990035/S006 · decided 2003-04-24
Approval details
- PMA number
- P990035
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SUNLIGHT OMNISENSE BONE SONOMETER
- Generic name
- Bone sonometer
- Applicant
- Beam-Med, Ltd.
- Date received
- 2002-11-01
- Decision date
- 2003-04-24
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- MUA
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Petach Tikva
- 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
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER (K110646) | Beam-Med, Ltd. | 2011-10-12 |