MC CUE PLC CUBA CLINICAL ULTRASONIC BONE SONOMETRY SYSTEM
FDA premarket approval P990016/S001 · decided 2001-11-08
Approval details
- PMA number
- P990016
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MC CUE PLC CUBA CLINICAL ULTRASONIC BONE SONOMETRY SYSTEM
- Generic name
- Bone sonometer
- Applicant
- CooperSurgical, Inc.
- Date received
- 2001-10-12
- Decision date
- 2001-11-08
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- MUA
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- APPROVAL FOR A SOFTWARE UPDATE FROM V4.2.0 TO V4.2.1 AND A NEW PHANTOM (QA COUPLER).
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