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FDA 510(k), K011827, ORTELIUS 800
FDA 510(k), K011827, ORTELIUS 800
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$149.00 USD
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510(K) Number: K011827
Device Name: ORTELIUS 800
Manufacturer: ORTHOSCAN LTD.
Device Classification Name: Goniometer, Ac-Powered
Regulation Number: 888.1500
Classification Product Code: KQX
Date Received: 06/12/2001
Decision Date: 08/28/2001
Regulation Medical Specialty: Orthopedic
Device Name: ORTELIUS 800
Manufacturer: ORTHOSCAN LTD.
Device Classification Name: Goniometer, Ac-Powered
Regulation Number: 888.1500
Classification Product Code: KQX
Date Received: 06/12/2001
Decision Date: 08/28/2001
Regulation Medical Specialty: Orthopedic
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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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