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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Monitoring, Perinatal
510(k) Number K971099
Device Name ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS5169
Applicant
ALEXANDER MFG. CO.
1511 S GARFIELD PL
MASON CITY,  IA  50401
Applicant Contact KEN HEIMENDINGER
Correspondent
ALEXANDER MFG. CO.
1511 S GARFIELD PL
MASON CITY,  IA  50401
Correspondent Contact KEN HEIMENDINGER
Regulation Number884.2740
Classification Product Code
HGM  
Date Received03/26/1997
Decision Date 06/05/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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