510(k) K781675

X-RAY COLLIMATOR by General X-Ray, Inc. — Product Code EHB

K781675 is an FDA 510(k) premarket notification submitted by General X-Ray, Inc. for the device "X-RAY COLLIMATOR". The FDA issued a decision of Substantially Equivalent on December 4, 1978. The device falls under product code EHB (Collimator, X-Ray), a Class I device regulated under 21 CFR 872.1840. General X-Ray, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1978
Date Received
September 29, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collimator, X-Ray
Device Class
Class I
Regulation Number
872.1840
Review Panel
RA
Submission Type