FDA.reportPublic FDA data

510(k) K031433

Device
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND SC 8000 WITH VF3 MODIFICATIONS
Applicant
Siemens Medical Solutions USA, Inc.
510(k) number
K031433
Product code
DSI
Decision
Substantially Equivalent (SESE)
Decision date
2003-08-19
Date received
2003-05-06
Regulation
870.1025
Classification name
Detector And Alarm, Arrhythmia
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
PENELOPE H GRECO
Address
16 Electronics Ave. Danvers MA US 01923 01923

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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