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FDA 510(k), K172695, AIR Anterior Array, AIR Posterior Array
FDA 510(k), K172695, AIR Anterior Array, AIR Posterior Array
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510(K) Number: K172695
Device Name: AIR Anterior Array, AIR Posterior Array
Manufacturer: Mary A. Mayka
Device Classification Name: Coil, Magnetic Resonance, Specialty
Regulation Number: MOS
Classification Product Code: 09/07/2017
Date Received: 11/22/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: AIR Anterior Array, AIR Posterior Array
Manufacturer: Mary A. Mayka
Device Classification Name: Coil, Magnetic Resonance, Specialty
Regulation Number: MOS
Classification Product Code: 09/07/2017
Date Received: 11/22/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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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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