Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | MC CUE PLC CUBA CLINICAL ULTRASONIC BONE SONOMETRY SYSTEM |
Generic Name | Bone sonometer |
Regulation Number | 892.1180 |
Applicant | CooperSurgical, Inc. 95 Corporate Dr. Trumbull, CT 06611 |
PMA Number | P990016 |
Supplement Number | S001 |
Date Received | 10/12/2001 |
Decision Date | 11/08/2001 |
Reclassified Date
|
08/18/2008 |
Product Code |
MUA |
Advisory Committee |
Radiology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A SOFTWARE UPDATE FROM V4.2.0 TO V4.2.1 AND A NEW PHANTOM (QA COUPLER). |
|
|