510(k) K921817
K921817 is an FDA 510(k) premarket notification submitted by Rifton Equipment For the Handicapped for the device "RIFTON MOR219 19 & RIFTON MOR225 25". The FDA issued a decision of Substantially Equivalent on April 29, 1992. The device falls under product code INM (Chair, With Casters), a Class I device regulated under 21 CFR 890.3100. Rifton Equipment For the Handicapped has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 1992
- Date Received
- April 15, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chair, With Casters
- Device Class
- Class I
- Regulation Number
- 890.3100
- Review Panel
- PM
- Submission Type