PMA P990016S002

Device: MCCUE CUBA CLINICAL ULTRASONIC BONE SONOMETRY SYSTEM
Applicant: CooperSurgical, Inc.
PMA number: P990016
Supplement: S002
Product code: MUA
Decision date: 2002-03-28
Generic name: Bone sonometer
Approval order 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 PRINTOUT SHOWS A GRAPHICAL DISPLAY OF PATIENT DATA.

Current openFDA PMA Record#

Device: MCCUE CUBA CLINICAL ULTRASONIC BONE SONOMETRY SYSTEM
Applicant: CooperSurgical, Inc.
PMA number: P990016
Supplement: S002
Product code: MUA
Generic name: Bone sonometer
Decision date: 2002-03-28
Decision code: APPR
Date received: 2002-01-16
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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 PRINTOUT SHOWS A GRAPHICAL DISPLAY OF PATIENT DATA.