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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Peripheral, Electric
510(k) Number K051635
Device Name DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES
Applicant
GE HEALTHCARE
86 PILGRIM ROAD
NEEDHAM,  MA  02492
Applicant Contact JOEL C KENT
Correspondent
GE HEALTHCARE
86 PILGRIM ROAD
NEEDHAM,  MA  02492
Correspondent Contact JOEL C KENT
Regulation Number868.2775
Classification Product Code
KOI  
Date Received06/20/2005
Decision Date 07/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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