510(k) K896275

JEDMED J-II CHAIR by Jedmed Instrument Co. — Product Code FRK

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