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FDA 510(k), K061365, CHECKPOINT WITH ACCUSTIM TECHNOLOGY
FDA 510(k), K061365, CHECKPOINT WITH ACCUSTIM TECHNOLOGY
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510(K) Number: K061365
Device Name: CHECKPOINT WITH ACCUSTIM TECHNOLOGY
Manufacturer: NDI MEDICAL, LLC
Device Classification Name: stimulator, nerve
Regulation Number: 874.1820
Classification Product Code: ETN
Date Received: 05/16/2006
Decision Date: 07/12/2006
Regulation Medical Specialty: Ear Nose & Throat
Device Name: CHECKPOINT WITH ACCUSTIM TECHNOLOGY
Manufacturer: NDI MEDICAL, LLC
Device Classification Name: stimulator, nerve
Regulation Number: 874.1820
Classification Product Code: ETN
Date Received: 05/16/2006
Decision Date: 07/12/2006
Regulation Medical Specialty: Ear Nose & Throat
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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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