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FDA 510(k), K092219, NAVIGATOR CLINICAL GUIDENCE SYSTEM
FDA 510(k), K092219, NAVIGATOR CLINICAL GUIDENCE SYSTEM
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510(K) Number: K092219
Device Name: NAVIGATOR CLINICAL GUIDENCE SYSTEM
Manufacturer: APPLIED PHYSIOLOGY PTY LTD.
Device Classification Name: Computer, Diagnostic, Pre-Programmed, Single-Function
Regulation Number: 870.1435
Classification Product Code: DXG
Date Received: 07/22/2009
Decision Date: 05/12/2010
Regulation Medical Specialty: Cardiovascular
Device Name: NAVIGATOR CLINICAL GUIDENCE SYSTEM
Manufacturer: APPLIED PHYSIOLOGY PTY LTD.
Device Classification Name: Computer, Diagnostic, Pre-Programmed, Single-Function
Regulation Number: 870.1435
Classification Product Code: DXG
Date Received: 07/22/2009
Decision Date: 05/12/2010
Regulation Medical Specialty: Cardiovascular
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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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