DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE


Device Classification Name

monitor, st segment with alarm

510(k) Number K022740
Device Name DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE
Original Applicant
DATEX-OHMEDA
86 pilgrim rd.
needham, 
MA 
02492

Original Contact joel c kent
Regulation Number 870.1025
Classification Product Code
MLD  
Date Received 08/19/2002
Decision Date 11/14/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls