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FDA 510(k), K953257, ORALSENSOR
FDA 510(k), K953257, ORALSENSOR
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510(K) Number: K953257
Device Name: ORALSENSOR
Manufacturer: KENT ANDERSON
Device Classification Name: Device, Biofeedback
Regulation Number: HCC
Classification Product Code: 07/12/1995
Date Received: 02/27/1996
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: ORALSENSOR
Manufacturer: KENT ANDERSON
Device Classification Name: Device, Biofeedback
Regulation Number: HCC
Classification Product Code: 07/12/1995
Date Received: 02/27/1996
Decision Date: Substantially Equivalent (SESE)
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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