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FDA 510(k), K153605, ivWatch Model 400
FDA 510(k), K153605, ivWatch Model 400
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$149.00 USD
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510(K) Number: K153605
Device Name: ivWatch Model 400
Manufacturer: ivWatch, LLC
Device Classification Name: Peripheral Intravenous (Piv) Infiltration Monitor
Regulation Number: 880.5725
Classification Product Code: PMS
Date Received: 12/17/2015
Decision Date: 02/11/2016
Regulation Medical Specialty: General Hospital
Device Name: ivWatch Model 400
Manufacturer: ivWatch, LLC
Device Classification Name: Peripheral Intravenous (Piv) Infiltration Monitor
Regulation Number: 880.5725
Classification Product Code: PMS
Date Received: 12/17/2015
Decision Date: 02/11/2016
Regulation Medical Specialty: General Hospital
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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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