DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE


Device Classification Name

detector and alarm, arrhythmia

510(k) Number K021376
Device Name DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE
Original Applicant
DATEX-OHMEDA
86 pilgrim rd.
needham, 
MA 
02492

Original Contact joel c kent
Regulation Number 870.1025
Classification Product Code
DSI  
Date Received 05/01/2002
Decision Date 07/24/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No