Respire Medical Obtains FDA 510(k) Clearance for Oral Appliance

Respire Medical, a United States-based oral appliance manufacturer, received FDA 510(k) approval for its Respire Blue Series oral appliance.

Sleep apnea patients treated with the device can adjust it themselves, adding a level of comfort to the treatment, according to the company.

"I have been successfully using the Respire over the last year with follow-up testing and am very pleased to see FDA approval…" said Michael Gelb, DDS, co-developer of the Respire Blue Series.