FDA 510(k), K152482, Propeller Sensor Model 2014-R

FDA 510(k), K152482, Propeller Sensor Model 2014-R

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510(K) Number: K152482
Device Name: Propeller Sensor Model 2014-R
Manufacturer: DAVID HUBANKS
Device Classification Name: Nebulizer (Direct Patient Interface)
Regulation Number: CAF
Classification Product Code: KXA
Date Received: 08/31/2015
Decision Date: 03/04/2016
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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