LogoFDA 510(k) Search
Search Filters

Search Results

Found 39 results

510(k) Data Aggregation

    K Number
    K982896
    Device Name
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1998-10-21

    (65 days)

    Product Code
    LDD
    Regulation Number
    870.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALEXANDER MFG. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Replacement battery for Physio-Control 803704-01 Life-Pak 9 Low-Energy Cardiac Monitor/Defibrillator, 510(k) Number 935674. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.
    Device Description
    Replacement battery for Physio-Control 803704-01 Life-Pak 9 Low-Energy Cardiac Monitor/Defibrillator.
    Ask a Question
    K Number
    K981776
    Device Name
    ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1998-08-03

    (75 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALEXANDER MFG. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Replacement battery for Sabretek 6060 Homerun Volumetric Infusion Pump (K941984) (and other non-rechargeable 8.4 volt (9-volt) applications). This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.
    Device Description
    MC146X is a 8.4 volt/800 mAh battery pack which replaces Sabretek 6060 Homerun Volumetric Infustion Pump (K941984) and other 8.4 volt (9-volt) (K941984). applications battery
    Ask a Question
    K Number
    K981728
    Device Name
    ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1998-06-26

    (42 days)

    Product Code
    BZQ
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALEXANDER MFG. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Replacement battery for Nihon Kohden, Inc LifeScope 6 Portable Patient Monitor, 510(K) Number K862462. This battery is shipped only to customers who request a replacement battery for a particular device or to customers who specifically order this battery and therefore knows the intended use is as a replacement battery.
    Device Description
    Replacement Battery Part Number H134
    Ask a Question
    K Number
    K980224
    Device Name
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1998-04-02

    (70 days)

    Product Code
    MOQ
    Regulation Number
    878.4820
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALEXANDER MFG. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Replacement battery for IVAC Corp. 124915 Electronic Clinical Thermometer 2000, 510(k) Number K820409. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.
    Device Description
    Rechargeable Battery Part Number MS822
    Ask a Question
    K Number
    K974061
    Device Name
    RECHARGEABLE BATTERY PART NUMBER GL825-200
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1998-01-16

    (81 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALEXANDER MFG. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Replacement battery for Physio-Control 802565-01 Life Stat 200 Blood Pressure Monitor, 510(k) Number K831232. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.
    Device Description
    Replacement battery for Physio-Control 802565-01 Life Stat 200 Blood Pressure Monitor, 510(k) Number K831232.
    Ask a Question
    K Number
    K973851
    Device Name
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M12/630
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1998-01-05

    (89 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALEXANDER MFG. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Replacement battery for IVAC Corp. 125053 630 Volumetric Infusion Purnp, Infu-Check #1500, 510(k) Number K790373. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.
    Device Description
    Rechargeable Battery #M12/630
    Ask a Question
    K Number
    K973850
    Device Name
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1997-11-12

    (35 days)

    Product Code
    HFO
    Regulation Number
    884.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALEXANDER MFG. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Replacement battery for Sonicaid 1000-0007 Fetal Monitoring System D205, 510(k) Number K780487. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.
    Device Description
    Rechargeable Battery Part Number M007
    Ask a Question
    K Number
    K972746
    Device Name
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1997-10-21

    (90 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALEXANDER MFG. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Replacement battery for Physio-Control 800285-01 Life Pak 6 & 7 Monitor, 510(k) Number K810154. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.
    Device Description
    Replacement battery for Physio-Control 800285-01 Life Pak 6 & 7 Monitor
    Ask a Question
    K Number
    K972779
    Device Name
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS3030-P
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1997-10-20

    (87 days)

    Product Code
    MRZ
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALEXANDER MFG. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Replacement battery for Corpak 415A R200, VTR300D Enteral Pump, 510(k) Number K832167. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore the intended use is as a replacement battery.
    Device Description
    Rechargeable Battery Part Number MS3030P
    Ask a Question
    K Number
    K972780
    Device Name
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1997-10-20

    (87 days)

    Product Code
    MRZ
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALEXANDER MFG. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Replacement battery for Ross Laboratories, Div. of Abbott Labs Flexiflo II Infusion Pump, 510(k) Number K821661. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.
    Device Description
    Rechargeable Battery Part Number GL625
    Ask a Question

    Page 1 of 4