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FDA 510(k), K150900, Flexicare Heated Wire Breathing Systems
FDA 510(k), K150900, Flexicare Heated Wire Breathing Systems
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510(K) Number: K150900
Device Name: Flexicare Heated Wire Breathing Systems
Manufacturer: FLEXICARE MEDICAL LTD.
Device Classification Name: heater, breathing system w/wo controller (not humidifier or nebulizer
Regulation Number: 868.5270
Classification Product Code: BZE
Date Received: 04/03/2015
Decision Date: 05/15/2015
Regulation Medical Specialty: Anesthesiology
Device Name: Flexicare Heated Wire Breathing Systems
Manufacturer: FLEXICARE MEDICAL LTD.
Device Classification Name: heater, breathing system w/wo controller (not humidifier or nebulizer
Regulation Number: 868.5270
Classification Product Code: BZE
Date Received: 04/03/2015
Decision Date: 05/15/2015
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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