FDA 510(k), K142059, FOX MOBILE

FDA 510(k), K142059, FOX MOBILE

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510(K) Number: K142059
Device Name: FOX MOBILE
Manufacturer: PAUL DRYDEN
Device Classification Name: Nebulizer (Direct Patient Interface)
Regulation Number: CAF
Classification Product Code: KXA
Date Received: 07/29/2014
Decision Date: 01/09/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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