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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Gastrointestinal Motility (Electrical)
510(k) Number K980980
Device Name MOTILITY PROBE MODEL NUMBERS P31 THRU P38, P40 THRU P43 AND P50
Applicant
Konigsberg Instruments, Inc.
2000 Foothill Blvd.
Pasadena,  CA  91107
Applicant Contact ARLIN HANSON
Correspondent
Konigsberg Instruments, Inc.
2000 Foothill Blvd.
Pasadena,  CA  91107
Correspondent Contact ARLIN HANSON
Regulation Number876.1725
Classification Product Code
FFX  
Subsequent Product Code
FFT  
Date Received03/17/1998
Decision Date 06/15/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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