510(k) K905856

MODEL 556 MONITOR by Ge Medical Systems Information Technologies — Product Code DSF

K905856 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Information Technologies for the device "MODEL 556 MONITOR". The FDA issued a decision of Substantially Equivalent on January 11, 1991. The device falls under product code DSF (Recorder, Paper Chart), a Class I device regulated under 21 CFR 870.2810. Ge Medical Systems Information Technologies has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1991
Date Received
October 15, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Paper Chart
Device Class
Class I
Regulation Number
870.2810
Review Panel
CV
Submission Type