FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

HORIZON DISPLAY CONTROLLER PART # 266-200-010

K Number: K884423 · Decision May 31, 1989
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
77
Applicant Total
34
Review Days
224

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Basic Information

Device Name
HORIZON DISPLAY CONTROLLER PART # 266-200-010
K Number
K884423
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.2450
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Mennen Medical, Inc.
Date Received
October 19, 1988
Decision Date
May 31, 1989
Product Code
DXJ
Advisory Committee
Cardiovascular
Review Advisory Committee
CV
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
DXJ Display, Cathode-Ray Tube, Medical

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Other Clearances by Mennen Medical, Inc.

K Number Device Name
K030722 ENVOY PATIENT MONITOR
K983864 ETCO2 VITAL SIGNS MODULE
K991775 MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS
K982697 MODIFICATION TO ENSEMBLE CENTRAL STATION MONITOR
K974510 ENVOY PATIENT MONITOR
K970358 ENSEMBLE CENTRAL STATION MONITOR
K940081 MERCURY
K940415 HORIZON 9000 WS
K920915 CAPNOMED 100 STAND-ALONE ETCO2 MODULE
K914381 HORIZON 9000/HIS OPTION AMPLIFIER
Search all 34 clearances from Mennen Medical, Inc. →