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FDA 510(k), K033710, MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU
FDA 510(k), K033710, MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU
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510(K) Number: K033710
Device Name: MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU
Manufacturer: FISHER & PAYKEL HEALTHCARE, LTD.
Device Classification Name: humidifier, respiratory gas, (direct patient interface)
Regulation Number: 868.5450
Classification Product Code: BTT
Date Received: 11/26/2003
Decision Date: 04/13/2004
Regulation Medical Specialty: Anesthesiology
Device Name: MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU
Manufacturer: FISHER & PAYKEL HEALTHCARE, LTD.
Device Classification Name: humidifier, respiratory gas, (direct patient interface)
Regulation Number: 868.5450
Classification Product Code: BTT
Date Received: 11/26/2003
Decision Date: 04/13/2004
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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