510(k) K840787
K840787 is an FDA 510(k) premarket notification submitted by Contour, Inc. for the device "CRAFTMATIC ELECTRIC ADJUSTABLE BED". The FDA issued a decision of Substantially Equivalent on June 13, 1984. The device falls under product code LLI (Bed, Therapeutic, Ac-Powered, Adjustable Home-Use), a Class II device regulated under 21 CFR 880.5100.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 1984
- Date Received
- January 20, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
- Device Class
- Class II
- Regulation Number
- 880.5100
- Review Panel
- HO
- Submission Type