510(k) K050919

LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P by Analogic Corp. — Product Code DSI

K050919 is an FDA 510(k) premarket notification submitted by Analogic Corp. for the device "LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P". The FDA issued a decision of Substantially Equivalent on Jun 14, 2005. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Analogic Corp. has 31 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 14, 2005
Date Received
Apr 12, 2005
Clearance Type
Abbreviated
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
510(k)