510(k) K831781

SERVOMED BASIC BEDSIDE UNIT SMVIII W by Litton Medical Electronics — Product Code DXJ

K831781 is an FDA 510(k) premarket notification submitted by Litton Medical Electronics for the device "SERVOMED BASIC BEDSIDE UNIT SMVIII W". The FDA issued a decision of Substantially Equivalent on November 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 at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1983
Date Received
June 2, 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