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Multiple 510(k)s – DEN210046, K152954, K140586, K223797
Multiple 510(k)s – DEN210046, K152954, K140586, K223797
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510(K) Number: K152954
Device Name: Quell
Manufacturer: NEUROMETRIX, INC.
Device Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter
Regulation Number: 882.5890
Classification Product Code: NUH
Date Received: 10/07/2015
Decision Date: 01/05/2016
Regulation Medical Specialty: Neurology
Request Contents: 510ks: DEN210046 K152954 K140586 K223797
Device Name: Quell
Manufacturer: NEUROMETRIX, INC.
Device Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter
Regulation Number: 882.5890
Classification Product Code: NUH
Date Received: 10/07/2015
Decision Date: 01/05/2016
Regulation Medical Specialty: Neurology
Request Contents: 510ks: DEN210046 K152954 K140586 K223797
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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