510(k) K832022

SERVOMED SMC 108/111-426-24, 111-426 by Litton Medical Electronics — Product Code DXJ

K832022 is an FDA 510(k) premarket notification submitted by Litton Medical Electronics for the device "SERVOMED SMC 108/111-426-24, 111-426". The FDA issued a decision of Substantially Equivalent on Nov 16, 1983. The device falls under product code DXJ (Display, Cathode-Ray Tube, Medical), a Class II device regulated under 21 CFR 870.2450. Litton Medical Electronics has 37 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 16, 1983
Date Received
Jun 23, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Display, Cathode-Ray Tube, Medical
Device Class
Class II
Regulation Number
870.2450
Review Panel
CV
Submission Type
510(k)