Proprietary Name: Zzoma; Zzoma Positional Device; Zzoma Positional Sleeper
Classification Name: PILLOW,CERVICAL(FOR MILD SLEEP APNEA)
Product Code: MYB
Device Class: 2
Regulation Number: 872.5570
Medical Specialty: Dental
Registered Establishment Name: Sleep Specialists, LLC
Registered Establishment Number: 3008812550
Premarket Submission Number: K100160
Owner/Operator: Sleep Specialists, LLC
Owner/Operator Number: 10034700
Establishment Operations: Specification Developer