510(k) K884531

BETA 90/50 MOBILE IMAGING TABLE by Beta Medical Products Co. — Product Code IXR

K884531 is an FDA 510(k) premarket notification submitted by Beta Medical Products Co. for the device "BETA 90/50 MOBILE IMAGING TABLE". The FDA issued a decision of Substantially Equivalent on January 11, 1989. The device falls under product code IXR (Table, Radiographic, Tilting), a Class II device regulated under 21 CFR 892.1980. Beta Medical Products Co. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1989
Date Received
October 28, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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