510(k) K820823

MULTIPLE, MODEL #17 by Midmark Corp. — Product Code LGX

K820823 is an FDA 510(k) premarket notification submitted by Midmark Corp. for the device "MULTIPLE, MODEL #17". The FDA issued a decision of Substantially Equivalent on April 21, 1982. 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
April 21, 1982
Date Received
March 24, 1982
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