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FDA 510(k), K133502, 5000Z FIREFLY SYSTEM
FDA 510(k), K133502, 5000Z FIREFLY SYSTEM
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510(K) Number: K133502
Device Name: 5000Z FIREFLY SYSTEM
Manufacturer: PRIZM MEDICAL, INC.
Device Classification Name: stimulator, nerve, transcutaneous, over-the-counter
Regulation Number: 882.5890
Classification Product Code: NUH
Date Received: 11/14/2013
Decision Date: 12/03/2014
Regulation Medical Specialty: Neurology
Device Name: 5000Z FIREFLY SYSTEM
Manufacturer: PRIZM MEDICAL, INC.
Device Classification Name: stimulator, nerve, transcutaneous, over-the-counter
Regulation Number: 882.5890
Classification Product Code: NUH
Date Received: 11/14/2013
Decision Date: 12/03/2014
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. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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