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FDA 510(k), K161314, FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE
FDA 510(k), K161314, FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE
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510(K) Number: K161314
Device Name: FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE
Manufacturer: FLEXICARE MEDICAL LIMITED
Device Classification Name: humidifier, respiratory gas, (direct patient interface)
Regulation Number: 868.5450
Classification Product Code: BTT
Date Received: 05/11/2016
Decision Date: 07/06/2016
Regulation Medical Specialty: Anesthesiology
Device Name: FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE
Manufacturer: FLEXICARE MEDICAL LIMITED
Device Classification Name: humidifier, respiratory gas, (direct patient interface)
Regulation Number: 868.5450
Classification Product Code: BTT
Date Received: 05/11/2016
Decision Date: 07/06/2016
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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