Serena Sleep Night Guard
K-Number: K230495 · 2023-10-13
ApplicantMeris Investment Group
Decision Date2023-10-13
Product CodeMQC
DecisionSubstantially Equivalent
Device Summary
Serena Sleep Night Guard is a medical device manufactured by Meris Investment Group. It received FDA 510(k) clearance on 2023-10-13 under approval number K230495. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Serena Sleep Night Guard?
Serena Sleep Night Guard is a medical device that received FDA 510(k) clearance on 2023-10-13. It is manufactured by Meris Investment Group. The 510(k) number is K230495.
When was Serena Sleep Night Guard approved by the FDA?
Serena Sleep Night Guard received FDA 510(k) clearance on 2023-10-13, under approval number K230495.
What company makes Serena Sleep Night Guard?
Serena Sleep Night Guard is manufactured by Meris Investment Group.
What is the FDA product code for Serena Sleep Night Guard?
The FDA product code for Serena Sleep Night Guard is MQC.
Related Clinical Trials
NCT07606495
Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients
NOT_YET_RECRUITING
NCT07611643
Bruxism Therapy of Facial Pain
RECRUITING
NCT07588659
Retail-Grade Weighted Blanket Effectiveness on ADHD-related Sleep Disturbances (BEAD)
NOT_YET_RECRUITING
NCT07608614
Sleep and Performance
RECRUITING
NCT06915012
Impact of Biophoton Therapy on Chronic Severe Arthritis Pain
RECRUITING
NCT04963205
Sleeping Position Study in COPD Patients
COMPLETED
Other Devices by Meris Investment Group
Related Devices (Code: MQC)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.