510(k) K901771

SIEMENS SIRECUST 732, PATIENT MONITOR by Siemens Medical Electronics — Product Code DPS

K901771 is an FDA 510(k) premarket notification submitted by Siemens Medical Electronics for the device "SIEMENS SIRECUST 732, PATIENT MONITOR". The FDA issued a decision of Substantially Equivalent on May 30, 1990. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Siemens Medical Electronics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1990
Date Received
April 19, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type