510(k) K926411
K926411 is an FDA 510(k) premarket notification submitted by Arjo-Century, Inc. for the device "SAF-LIFT/SAF-KARY". The FDA issued a decision of Substantially Equivalent on March 31, 1993. The device falls under product code FNG (Lift, Patient, Ac-Powered), a Class II device regulated under 21 CFR 880.5500. Arjo-Century, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 1993
- Date Received
- December 21, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lift, Patient, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 880.5500
- Review Panel
- HO
- Submission Type