510(k) K894134

POWER EXAMINATION TABLE MODEL # 411 by Midmark Corp. — Product Code LGX

K894134 is an FDA 510(k) premarket notification submitted by Midmark Corp. for the device "POWER EXAMINATION TABLE MODEL # 411". The FDA issued a decision of Substantially Equivalent on August 28, 1989. The device falls under product code LGX (Table, Examination, Medical, Powered), a Class I device regulated under 21 CFR 878.4960. Midmark Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1989
Date Received
June 13, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Examination, Medical, Powered
Device Class
Class I
Regulation Number
878.4960
Review Panel
HO
Submission Type