BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500

    K Number: K141795 · Decision Dec 8, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    227
    Applicant Total
    53
    Review Days
    158

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    Basic Information

    Device Name
    BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500
    K Number
    K141795
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    R & D Batteries, Inc.
    Date Received
    July 3, 2014
    Decision Date
    December 8, 2014
    Product Code
    MKJ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MKJ Automated External Defibrillators (Non-Wearable)

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    Other Clearances by R & D Batteries, Inc.

    K Number Device Name
    K951282 R&D BATTERIES, INC. PART NUMBERS 5039, 5052, 5056 AND 5061
    K951284 R&D BATTERIES, INC. PART NUMBERS 5137, 5140, 5142 AND 5155
    K951402 R&D BATTERIES PART NOS. 5167, 5221, 5244 AND 5247
    K951281 R&D BATTERIS, INC. PART NUMBER 5024, 5027, 5033 AND 5035
    K951276 R&D BATTERIES, INC. PART NUMBERS 5412, 5420, 5436 AND 5438
    K951279 R&D BATTEERIES, INC. PART NUMBERS 5173, 5178, 5197 AND 5199
    K951399 R&D BATTERIES PART NOS. 5041 & 5655
    K951274 R&D BATTRIES, INC. PART NUMBERS 5601, 5602, 5624 AND 5626
    K951404 R&D BATTERIES PART NOS. 5096, 5115, 5128 AND 5131
    K951400 R&D BATTERIES PART NOS. 5064, 5157, 5489 AND 5536
    Search all 53 clearances from R & D Batteries, Inc. →