510(k) K861940

RADIOGRAPHIC TABLES MODELS A71OS-T,A71OT-T,A71OB-T by D&R X-Ray Products, Inc. — Product Code IZZ

K861940 is an FDA 510(k) premarket notification submitted by D&R X-Ray Products, Inc. for the device "RADIOGRAPHIC TABLES MODELS A71OS-T,A71OT-T,A71OB-T". The FDA issued a decision of Substantially Equivalent on May 29, 1986. The device falls under product code IZZ (Table, Radiographic, Non-Tilting, Powered), a Class II device regulated under 21 CFR 892.1980. D&R X-Ray Products, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1986
Date Received
May 20, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiographic, Non-Tilting, Powered
Device Class
Class II
Regulation Number
892.1980
Review Panel
RA
Submission Type