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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 K925159
Device Name TOF-GUARD TRANSMISSION MONITOR
Applicant
Biometer Intl. A/S
21 A/ Hans Egedesvej
Dk- - 5210 Odense Nv
Denmark,  DK
Applicant Contact FLEMMING HIMMELSTRUP
Correspondent
Biometer Intl. A/S
21 A/ Hans Egedesvej
Dk- - 5210 Odense Nv
Denmark,  DK
Correspondent Contact FLEMMING HIMMELSTRUP
Regulation Number868.2775
Classification Product Code
KOI  
Date Received10/13/1992
Decision Date 09/01/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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