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FDA 510(k), K163283, HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
FDA 510(k), K163283, HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
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510(K) Number: K163283
Device Name: HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
Manufacturer: HAMILTON MEDICAL AG
Device Classification Name: humidifier, respiratory gas, (direct patient interface)
Regulation Number: 868.5450
Classification Product Code: BTT
Date Received: 11/21/2016
Decision Date: 09/20/2017
Regulation Medical Specialty: Anesthesiology
Device Name: HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
Manufacturer: HAMILTON MEDICAL AG
Device Classification Name: humidifier, respiratory gas, (direct patient interface)
Regulation Number: 868.5450
Classification Product Code: BTT
Date Received: 11/21/2016
Decision Date: 09/20/2017
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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