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FDA 510(k), K142774, Polysmith Sleep System
FDA 510(k), K142774, Polysmith Sleep System
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510(K) Number: K142774
Device Name: Polysmith Sleep System
Manufacturer: Neurotronics, Inc.
Device Classification Name: standard polysomnograph with electroencephalograph
Regulation Number: 882.1400
Classification Product Code: OLV
Date Received: 09/26/2014
Decision Date: 02/18/2015
Regulation Medical Specialty: Neurology
Device Name: Polysmith Sleep System
Manufacturer: Neurotronics, Inc.
Device Classification Name: standard polysomnograph with electroencephalograph
Regulation Number: 882.1400
Classification Product Code: OLV
Date Received: 09/26/2014
Decision Date: 02/18/2015
Regulation Medical Specialty: Neurology
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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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