510(k) K842030

NEUTRAL POS-CHAIR SURGEON CHAIR by Neutral Pos-Chair Co. — Product Code FZK

K842030 is an FDA 510(k) premarket notification submitted by Neutral Pos-Chair Co. for the device "NEUTRAL POS-CHAIR SURGEON CHAIR". The FDA issued a decision of Substantially Equivalent on July 23, 1984. The device falls under product code FZK (Chair, Surgical, Non-Electrical), a Class I device regulated under 21 CFR 878.4950. Neutral Pos-Chair Co. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1984
Date Received
May 18, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, Surgical, Non-Electrical
Device Class
Class I
Regulation Number
878.4950
Review Panel
SU
Submission Type