510(k) K904187

ECONOMY C-ARM TABLE, MODEL # 056-005 by Atomic Products Corp. — Product Code IXQ

K904187 is an FDA 510(k) premarket notification submitted by Atomic Products Corp. for the device "ECONOMY C-ARM TABLE, MODEL # 056-005". The FDA issued a decision of Substantially Equivalent on November 29, 1990. The device falls under product code IXQ (Table, Radiographic, Stationary Top), a Class II device regulated under 21 CFR 892.1980. Atomic Products Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1990
Date Received
September 12, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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