FDA 510(k), K133670, HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE
FDA 510(k), K133670, HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE
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510(K) Number: K133670
Device Name: HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE
Manufacturer: NEOCOIL, LLC
Device Classification Name: system, nuclear magnetic resonance imaging
Regulation Number: 892.1000
Classification Product Code: LNH
Date Received: 11/29/2013
Decision Date: 07/24/2014
Regulation Medical Specialty: Radiology
Device Name: HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE
Manufacturer: NEOCOIL, LLC
Device Classification Name: system, nuclear magnetic resonance imaging
Regulation Number: 892.1000
Classification Product Code: LNH
Date Received: 11/29/2013
Decision Date: 07/24/2014
Regulation Medical Specialty: Radiology
- 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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