510(k) K113201
K113201 is an FDA 510(k) premarket notification submitted by Resmed Sas for the device "NARVAL CC". The FDA issued a decision of Substantially Equivalent on December 1, 2011. The device falls under product code LQZ (Device, Jaw Repositioning), a Class II device regulated under 21 CFR 872.5570. Resmed Sas has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 1, 2011
- Date Received
- October 31, 2011
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Jaw Repositioning
- Device Class
- Class II
- Regulation Number
- 872.5570
- Review Panel
- DE
- Submission Type