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510(k) Data Aggregation

    K Number
    K963305
    Device Name
    ALEXANDER BOX, BATTERY, RECHARGEABLE
    Manufacturer
    Date Cleared
    1997-04-17

    (238 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Product Code :

    BWA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Each battery pack is a replacement for the OEM battery pack. Each is used in the Each battery pack is a replacement for the original batteries supplied with the original equipment. In summary, the indication for use is to power the device to which the battery pack is configured.
    Device Description
    Alexander Manufacturing Company battery part nos. MS5R225, MS501 and MS8400 are all nickel-cadmium (NiCad) battery packs comprised of cells produced by either Saft or Sanyo. The H132 is a mercury cell produced by Alexander Manufacturing. Part number GL625 is a lead-acid battery. Each battery pack is rechargeable (except for H132) just as the original equipment manufacturer's (OEM) battery packs are. The cells are assembled into battery packs at Alexander Manufacturing Company's facility in Mason City, Iowa. The packs are assembled under the auspices of 21 CFR Part 820 Good Manufacturing Practice for Medical Devices (GMP) and ISO 9001. - MS5R225 is a 6.0V/2.5 Ah battery pack for use with the ANTEK Medical Telemetry - MS501 is a 4.8V/1.2 Ah battery pack for use with the BIO-TEK Safety Analyzer Model 501. - H132 is a 2.8V/1.0 Ah battery pack for use with the Corometrics Medical PH Meter - MS8400 is a 6.0V/1.2 Ah battery pack for use with the International Technidyne Corp. Hemochron 400 and Blood Coagulator Timer. - GL625 is a 6.0V/2.5 Ah battery pack for use with the Syborn Corp. ACT Blood Pressure Monitor and Portable Blood Coagulator.
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