510(k) K896275
K896275 is an FDA 510(k) premarket notification submitted by Jedmed Instrument Co. for the device "JEDMED J-II CHAIR". The FDA issued a decision of Substantially Equivalent on December 18, 1989. The device falls under product code FRK (Chair, Examination And Treatment), a Class I device regulated under 21 CFR 880.6140. Jedmed Instrument Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 1989
- Date Received
- October 30, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chair, Examination And Treatment
- Device Class
- Class I
- Regulation Number
- 880.6140
- Review Panel
- HO
- Submission Type