510(k) K931283

MICROVISION FAST DETAIL INTENSIFYING SCREEN by E.I. Dupont DE Nemours & Co., Inc. — Product Code EAM

K931283 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "MICROVISION FAST DETAIL INTENSIFYING SCREEN". The FDA issued a decision of Substantially Equivalent on June 8, 1993. The device falls under product code EAM (Screen, Intensifying, Radiographic), a Class I device regulated under 21 CFR 892.1960. 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
June 8, 1993
Date Received
March 12, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screen, Intensifying, Radiographic
Device Class
Class I
Regulation Number
892.1960
Review Panel
RA
Submission Type