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FDA 510(k), K140054, RESCAN
FDA 510(k), K140054, RESCAN
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510(K) Number: K140054
Device Name: RESCAN
Manufacturer: RESMED LTD
Device Classification Name: Ventilator, Non-Continuous (Respirator)
Regulation Number: 868.5905
Classification Product Code: BZD
Date Received: 01/09/2014
Decision Date: 05/16/2014
Regulation Medical Specialty: Anesthesiology
Device Name: RESCAN
Manufacturer: RESMED LTD
Device Classification Name: Ventilator, Non-Continuous (Respirator)
Regulation Number: 868.5905
Classification Product Code: BZD
Date Received: 01/09/2014
Decision Date: 05/16/2014
Regulation Medical Specialty: Anesthesiology
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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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