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FDA 510(k), K172079, Avail
FDA 510(k), K172079, Avail
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510(K) Number: K172079
Device Name: Avail
Manufacturer: Omron Healthcare, Inc.
Device Classification Name: stimulator, nerve, transcutaneous, over-the-counter
Regulation Number: 882.5890
Classification Product Code: NUH
Date Received: 07/10/2017
Decision Date: 10/19/2017
Regulation Medical Specialty: Neurology
Device Name: Avail
Manufacturer: Omron Healthcare, Inc.
Device Classification Name: stimulator, nerve, transcutaneous, over-the-counter
Regulation Number: 882.5890
Classification Product Code: NUH
Date Received: 07/10/2017
Decision Date: 10/19/2017
Regulation Medical Specialty: Neurology
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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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