510(k) K853421
K853421 is an FDA 510(k) premarket notification submitted by Keymed, Inc. for the device "THE KEYMED VARI-HEIGHT PATIENT COUCH". The FDA issued a decision of Substantially Equivalent on September 19, 1985. The device falls under product code FPO (Stretcher, Wheeled), a Class II device regulated under 21 CFR 880.6910. Keymed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 19, 1985
- Date Received
- August 14, 1985
- 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