510(k) K792305
K792305 is an FDA 510(k) premarket notification submitted by Farrall Instruments, Inc. for the device "A SLEEP ASSESSMENT DEVICE". The FDA issued a decision of Substantially Equivalent on December 20, 1979. The device falls under product code LEL (Device, Sleep Assessment), a Class II device regulated under 21 CFR 882.5050. Farrall Instruments, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 1979
- Date Received
- November 16, 1979
- 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