SUNLIGHT OMNISENSE 7000S ULTRASOUND BONE SONOMETER
FDA premarket approval P990035/S003 · decided 2002-05-24
Approval details
- PMA number
- P990035
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SUNLIGHT OMNISENSE 7000S ULTRASOUND BONE SONOMETER
- Generic name
- Bone sonometer
- Applicant
- Beam-Med, Ltd.
- Date received
- 2001-08-10
- Decision date
- 2002-05-24
- Days to decision
- 287 days
- Decision code
- APPR
- Product code
- MUA
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Petach Tikva
- 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.
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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 |