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510(k) Premarket Notification Database

Device Classification Name electrocardiograph
510(k) NumberK970787
Device NameALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3)
Applicant
ALEXANDER MFG. CO.
1511 s garfield pl
mason city,  IA  50401
Contactstacey hippen
Regulation Number870.2340
Classification Product Code
DPS
Date Received03/04/1997
Decision Date 05/14/1997
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Anesthesiology
Statement/Summary/Purged Status Statement only
Type Traditional
Reviewed by Third Party No
Expedited Review No

Database Updated 01/16/2009

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