MCCUE CUBACLINICAL ULTRASONIC BONE SONOMETRY SYSTEM WITH CUBAPLUS+ V4.1.0
FDA premarket approval P990016 · decided 2000-01-07
Approval details
- PMA number
- P990016
- Trade name
- MCCUE CUBACLINICAL ULTRASONIC BONE SONOMETRY SYSTEM WITH CUBAPLUS+ V4.1.0
- Generic name
- Bone sonometer
- Applicant
- CooperSurgical, Inc.
- Date received
- 1999-03-08
- Decision date
- 2000-01-07
- Days to decision
- 305 days
- Decision code
- APRL
- Product code
- MUA
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- Approval to perform a quantitative ultrasound measurement of the calcaneus (heel bone), the results of which can be used in conjunction with other clinical risk factors as an aid for the diagnosis of osteoporosis and other medical conditions leading to reduced bone density and, ultimately, for the determination of fracture risk.
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