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FDA 510(k), K082402, OSDX HIP BMD SYSTEM
FDA 510(k), K082402, OSDX HIP BMD SYSTEM
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510(K) Number: K082402
Device Name: OSDX HIP BMD SYSTEM
Manufacturer: PATRICK HESS
Device Classification Name: Densitometer, Bone
Regulation Number: KGI
Classification Product Code: 08/20/2008
Date Received: 10/16/2008
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: OSDX HIP BMD SYSTEM
Manufacturer: PATRICK HESS
Device Classification Name: Densitometer, Bone
Regulation Number: KGI
Classification Product Code: 08/20/2008
Date Received: 10/16/2008
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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