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Continuous, Ventilator, Home Use

FDA product code NOU · 7 cleared devices

Class 2 Anesthesiology
Regulation
21 CFR 868.5895
Review panel
AN
Implant
No
Life sustaining
Yes
Third party review
No
GMP exempt
No
Clearance span
2003-08-13 – 2025-01-13

This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device.

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