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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K972786
Device Name ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL9366
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 Number870.2700
Classification Product Code
DQA  
Date Received07/25/1997
Decision Date 10/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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