510(k) K862441
K862441 is an FDA 510(k) premarket notification submitted by Ferno-Washington, Inc. for the device "EZ LOAD MODEL 30, ALL LEVEL COT". The FDA issued a decision of Substantially Equivalent on September 12, 1986. The device falls under product code FPO (Stretcher, Wheeled), a Class II device regulated under 21 CFR 880.6910. Ferno-Washington, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 1986
- Date Received
- June 26, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stretcher, Wheeled
- Device Class
- Class II
- Regulation Number
- 880.6910
- Review Panel
- HO
- Submission Type