DATEX-OHMEDA HMEF 500


Device Classification Name

filter, bacterial, breathing-circuit

510(k) Number K021265
Device Name DATEX-OHMEDA HMEF 500
Original Applicant
DATEX-OHMEDA
86 pilgrim rd.
needham, 
MA 
02492

Original Contact joel c kent
Regulation Number 868.5260
Classification Product Code
CAH  
Date Received 04/22/2002
Decision Date 08/30/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No