510(k) K111207

RESPIRE BLUE SERIES by Respire Medical — Product Code LRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2011
Date Received
April 29, 2011
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Anti-Snoring
Device Class
Class II
Regulation Number
872.5570
Review Panel
DE
Submission Type