OMNISENSE 7000S ULTRASOUND BONE SONOMETER
FDA premarket approval P990035/S001 · decided 2001-06-21
Approval details
- PMA number
- P990035
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- OMNISENSE 7000S ULTRASOUND BONE SONOMETER
- Generic name
- Bone sonometer
- Applicant
- Beam-Med, Ltd.
- Date received
- 2000-06-26
- Decision date
- 2001-06-21
- Days to decision
- 360 days
- Decision code
- APPR
- Product code
- MUA
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Petach Tikva
- Statement
- APPROVAL FOR THE ADDITION OF TWO NEW PROBES FOR USE ON TWO ADDITIONAL SKELETAL SITES, THE PROXIMAL THIRD PHALANX AND THE FIFTH METATARSAL. THE DEVICE, AS MODIFIED, IS INDICATED AS FOLLOWS: "A NONINVASIVE DEVICE THAT IS DESIGNED FOR THE QUANTITATIVE MEASUREMENT OF THE SIGNAL VELOCITY OF ULTRASONIC WAVES ("SPEED OF SOUND" OR "SOS" IN M/SEC) PROPAGATING AT MULTIPLE SKELETAL SITES (I.E., THE DISTAL ONE-THIRD OF THE RADIUS, THE PROXIMAL THIRD PHALANX, AND THE FIFTH METATARSAL). SOS PROVIDES AN ESTIMA
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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 |