PLC

9 FDA 510(k) clearances · Product code

FDA profile

Official device name

Sleep Appliances With Patient Monitoring

Device class

Class II (moderate risk)

Regulation

21 CFR 872.5570

Medical specialty

Dental

Flags

Third-party review eligible

FDA definition

For the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older while also measuring patient compliance to oral appliance therapy.

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