BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    R AND D BATTERIES

    K Number: K935427 · Decision Oct 21, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    37
    Applicant Total
    53
    Review Days
    345

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    R AND D BATTERIES
    K Number
    K935427
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1540
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    R & D Batteries, Inc.
    Date Received
    November 10, 1993
    Decision Date
    October 21, 1994
    Product Code
    JAF
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JAF Monitor, Ultrasonic, Nonfetal

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JAF), ordered by most recent decision date.

    Laminar P1 (LDH-HW-001)

    FDA 510(k)
    FDA Class 2 ·Radiology

    THD REVOLUTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    SIMPLEABI

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIFEDOP MODEL 300ABI

    FDA 510(k)
    FDA Class 2 ·Radiology

    THD SLIDE ONE

    FDA 510(k)
    FDA Class 2 ·Radiology

    THD SLIDE

    FDA 510(k)
    FDA Class 2 ·Radiology
    View all

    Other Clearances by R & D Batteries, Inc.

    K Number Device Name
    K141795 BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500
    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
    Search all 53 clearances from R & D Batteries, Inc. →