510(k) K771748

INTRA ORAL X-RAY CONES by General Electric Co. — Product Code EAH

K771748 is an FDA 510(k) premarket notification submitted by General Electric Co. for the device "INTRA ORAL X-RAY CONES". The FDA issued a decision of Substantially Equivalent on September 28, 1977. The device falls under product code EAH (Cone, Radiographic, Lead-Lined), a Class I device regulated under 21 CFR 872.1850. General Electric Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1977
Date Received
September 15, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cone, Radiographic, Lead-Lined
Device Class
Class I
Regulation Number
872.1850
Review Panel
RA
Submission Type