• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
New Search Back to Search Results
Device expiratory resistance valve, intranasal, for obstructive sleep apnea
Regulation Description Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
Definition Intranasal device that creates expiratory resistance for the treatment of obstructive sleep apnea.
Physical State plastic with adhesive; valve that changes position with inspiration/expiration to provide decreased/increased resistance
Technical Method intranasal device that creates expiratory resistance
Target Area inserted into nares of nose to maintain upper airway pressure.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeOHP
Premarket Review Division of Dental and ENT Devices (DHT1B)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.5570
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review
Accredited Persons