510(k) K894460

SIEMENS SIRECUST 730, PATIENT MONITOR W/ARRHYTHMIA by Siemens Medical Electronics — Product Code DSI

K894460 is an FDA 510(k) premarket notification submitted by Siemens Medical Electronics for the device "SIEMENS SIRECUST 730, PATIENT MONITOR W/ARRHYTHMIA". The FDA issued a decision of Substantially Equivalent on October 2, 1989. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Siemens Medical Electronics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1989
Date Received
July 18, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type