MCCUE CUBA CLINICAL ULTRASONIC BONE SONOMETRY SYSTEM
FDA premarket approval P990016/S002 · decided 2002-03-28
Approval details
- PMA number
- P990016
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MCCUE CUBA CLINICAL ULTRASONIC BONE SONOMETRY SYSTEM
- Generic name
- Bone sonometer
- Applicant
- CooperSurgical, Inc.
- Date received
- 2002-01-16
- Decision date
- 2002-03-28
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- MUA
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- APPROVAL OF THE CUBACLINICAL DATA CONTROLLER (DATA CONTROLLER). THE DATA CONTROLLER IS A HAND-HELD CONTROL DEVICE THAT ENABLES THE USER TO OPERATE THE CUBACLINICAL WITHOUT THE COMPUTER AND THE SOFTWARE FOR DATA ANALYSIS. THE MODIFICATIONS TO THE BONE SONOMETER CONSIST OF THE INTEGRATION OF THE DATA CONTROLLER AND ASSOCIATED SOFTWARE, SIMPLE REPLACEMENT OF THE CUBACLINICAL SERIAL CONNECTOR, AND DATA CONTROLLER OPERATING INSTRUCTIONS. THE RESULTS ARE DISPLAYED ON AN LCD SCREEN DISPLAY AND THE PRIN
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