510(k) Submission – ProChamber Valved Holding Chamber (K032809, Respironics)

510(k) Submission – ProChamber Valved Holding Chamber (K032809, Respironics)

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510(K) Number: K032809
Device Name: HOSPITAL SPACER
Manufacturer: RESPIRONICS HEALTHSCAN, INC.
Device Classification Name: Nebulizer (Direct Patient Interface)
Regulation Number: 868.5630
Classification Product Code: CAF
Date Received: 09/09/2003
Decision Date: 11/13/2003
Regulation Medical Specialty: Anesthesiology
Request Contents: K032809 for ProChamber Valved Holding Chamber By Respironics
  • 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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