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

    EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED

    K Number: K080473 · Decision Sep 3, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    258
    Applicant Total
    26
    Review Days
    195

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    Basic Information

    Device Name
    EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED
    K Number
    K080473
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6180
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medicult A/S
    Date Received
    February 21, 2008
    Decision Date
    September 3, 2008
    Product Code
    MQL
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MQL Media, Reproductive

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    Other Clearances by Medicult A/S

    K Number Device Name
    K080172 BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216
    K081639 ICSI CUMULASE
    K061309 EMBRYOASSIST
    K061145 SPERMSLOW
    K060983 BIOPSY MEDIUM, MODEL REF 1062
    K060699 SYNVITRO CUMULASE (HYALURONIDASE MEDIUM)
    K041284 MEDICULT IVM SYSTEM
    K030490 ISM1+, IMS2+, AND UTM+
    K031486 BLASTFREEZE AND BLASTTHAW
    K031228 SYNVITRO HYADASE
    Search all 26 clearances from Medicult A/S →