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510(k) Submission – ProChamber Valved Holding Chamber (K992917, Respironics HealthScan)
510(k) Submission – ProChamber Valved Holding Chamber (K992917, Respironics HealthScan)
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510(K) Number: K992917
Device Name: AEROCHAMBER PLUS VALVED HOLDING CHAMBER
Manufacturer: TRUDELL MEDICAL INT'L
Device Classification Name: Nebulizer (Direct Patient Interface)
Regulation Number: 868.5630
Classification Product Code: CAF
Date Received: 08/30/1999
Decision Date: 09/14/1999
Regulation Medical Specialty: Anesthesiology
Request Contents: K992917 for ProChamber Valved Holding Chamber by Respironics HealthScan
Device Name: AEROCHAMBER PLUS VALVED HOLDING CHAMBER
Manufacturer: TRUDELL MEDICAL INT'L
Device Classification Name: Nebulizer (Direct Patient Interface)
Regulation Number: 868.5630
Classification Product Code: CAF
Date Received: 08/30/1999
Decision Date: 09/14/1999
Regulation Medical Specialty: Anesthesiology
Request Contents: K992917 for ProChamber Valved Holding Chamber by Respironics HealthScan
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- 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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