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: KXA
Date Received: 09/07/2017
Decision Date: 11/22/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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