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FDA 510(k), K122432, ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS
FDA 510(k), K122432, ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS
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510(K) Number: K122432
Device Name: ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS
Manufacturer: FISHER & PAYKEL HEALTHCARE, LTD.
Device Classification Name: heater, breathing system w/wo controller (not humidifier or nebulizer
Regulation Number: 868.5270
Classification Product Code: BZE
Date Received: 08/10/2012
Decision Date: 12/06/2012
Regulation Medical Specialty: Anesthesiology
Device Name: ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS
Manufacturer: FISHER & PAYKEL HEALTHCARE, LTD.
Device Classification Name: heater, breathing system w/wo controller (not humidifier or nebulizer
Regulation Number: 868.5270
Classification Product Code: BZE
Date Received: 08/10/2012
Decision Date: 12/06/2012
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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