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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, gas, carbon-dioxide, gaseous-phase
510(k) Number K023454
Device Name DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE M-MINIC AND ACCESSORIES
Applicant
DATEX-OHMEDA
86 PILGRIM RD.
NEEDHAM,  MA  02492
Applicant Contact JOEL C KENT
Correspondent
DATEX-OHMEDA
86 PILGRIM RD.
NEEDHAM,  MA  02492
Correspondent Contact JOEL C KENT
Regulation Number868.1400
Classification Product Code
CCK  
Date Received10/15/2002
Decision Date 04/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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