SUNLIGHT OMNISENSE ULTRASOUND BONE SONOMETER
FDA premarket approval P990035/S002 · decided 2001-07-27
Approval details
- PMA number
- P990035
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- SUNLIGHT OMNISENSE ULTRASOUND BONE SONOMETER
- Generic name
- Bone sonometer
- Applicant
- Beam-Med, Ltd.
- Date received
- 2001-06-26
- Decision date
- 2001-07-27
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- MUA
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Petach Tikva
- Statement
- APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT SUNLIGHT MEDICAL LTD., TEL-AVIV, ISRAEL.
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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 |