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FDA 510(k), K160540, FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM
FDA 510(k), K160540, FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM
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510(K) Number: K160540
Device Name: FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM
Manufacturer: FLEXICARE MEDICAL LIMITED
Device Classification Name: heater, breathing system w/wo controller (not humidifier or nebulizer
Regulation Number: 868.5270
Classification Product Code: BZE
Date Received: 02/26/2016
Decision Date: 06/23/2016
Regulation Medical Specialty: Anesthesiology
Device Name: FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM
Manufacturer: FLEXICARE MEDICAL LIMITED
Device Classification Name: heater, breathing system w/wo controller (not humidifier or nebulizer
Regulation Number: 868.5270
Classification Product Code: BZE
Date Received: 02/26/2016
Decision Date: 06/23/2016
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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