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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
510(k) Number K921727
Device Name CORE MONITORING SYSTEM-SP1475/6275/5607/5708/4575
Applicant
Viggo-Spectramed
1900 Williams Dr.
Oxnard,  CA  93030
Applicant Contact CHERYL L SHEA
Correspondent
Viggo-Spectramed
1900 Williams Dr.
Oxnard,  CA  93030
Correspondent Contact CHERYL L SHEA
Regulation Number884.4160
Classification Product Code
KNF  
Date Received04/10/1992
Decision Date 05/10/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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