FDA 510(k), K180770, Propeller Sensor for Neohaler

FDA 510(k), K180770, Propeller Sensor for Neohaler

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510(K) Number: K180770
Device Name: Propeller Sensor for Neohaler
Manufacturer: Reciprocal Labs Corporation
Device Classification Name: nebulizer (direct patient interface)
Regulation Number: 868.5630
Classification Product Code: CAF
Date Received: 03/23/2018
Decision Date: 08/01/2018
Regulation Medical Specialty: Anesthesiology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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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