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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K972787
Device Name ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M850-P
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 Number870.2300
Classification Product Code
DRT  
Date Received07/25/1997
Decision Date 10/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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