510(k) K940309

X-RAY GRID (RADIOLOGICAL GRID) by J.P.I. Chicago Co. — Product Code IXJ

K940309 is an FDA 510(k) premarket notification submitted by J.P.I. Chicago Co. for the device "X-RAY GRID (RADIOLOGICAL GRID)". The FDA issued a decision of Substantially Equivalent on April 22, 1994. The device falls under product code IXJ (Grid, Radiographic), a Class I device regulated under 21 CFR 892.1910. J.P.I. Chicago Co. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1994
Date Received
January 24, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Grid, Radiographic
Device Class
Class I
Regulation Number
892.1910
Review Panel
RA
Submission Type