510(k) K922483

DU PONT COMPACT DAYLIGHT SYSTEM 2000 by E.I. Dupont DE Nemours & Co., Inc. — Product Code KPX

K922483 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "DU PONT COMPACT DAYLIGHT SYSTEM 2000". The FDA issued a decision of Substantially Equivalent on September 11, 1992. The device falls under product code KPX (Changer, Radiographic Film/Cassette), a Class II device regulated under 21 CFR 892.1860. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1992
Date Received
May 27, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Changer, Radiographic Film/Cassette
Device Class
Class II
Regulation Number
892.1860
Review Panel
RA
Submission Type