510(k) K761147
K761147 is an FDA 510(k) premarket notification submitted by F. & F. Koenigkramer for the device "RELIANCE MOD-U-LINE M-700". The FDA issued a decision of Substantially Equivalent on January 28, 1977. The device falls under product code FPO (Stretcher, Wheeled), a Class II device regulated under 21 CFR 880.6910. F. & F. Koenigkramer has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 28, 1977
- Date Received
- November 26, 1976
- 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