DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SOFTWARE


Device Classification Name

monitor, physiological, patient(with arrhythmia detection or alarms)

510(k) Number K021279
Device Name DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SOFTWARE
Original Applicant
DATEX-OHMEDA
86 pilgrim rd.
needham, 
MA 
02492

Original Contact joel c kent
Regulation Number 870.1025
Classification Product Code
MHX  
Subsequent Product Code
GWQ  
Date Received 04/22/2002
Decision Date 07/19/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No