FDA 510(k), K140211, ULTRASONIC MESH NEBULIZER

FDA 510(k), K140211, ULTRASONIC MESH NEBULIZER

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510(K) Number: K140211
Device Name: ULTRASONIC MESH NEBULIZER
Manufacturer: GUENTER GINSBERG
Device Classification Name: Nebulizer (Direct Patient Interface)
Regulation Number: CAF
Classification Product Code: KXA
Date Received: 01/28/2014
Decision Date: 05/30/2014
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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