510(k) K912817
K912817 is an FDA 510(k) premarket notification submitted by Somnitec, Inc. for the device "SOMNIMIC (R)". The FDA issued a decision of Substantially Equivalent on July 26, 1991. The device falls under product code LEL (Device, Sleep Assessment), a Class II device regulated under 21 CFR 882.5050. Somnitec, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 26, 1991
- Date Received
- May 21, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Sleep Assessment
- Device Class
- Class II
- Regulation Number
- 882.5050
- Review Panel
- NE
- Submission Type