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

    MightySat -OTC

    K Number: K214115 · Decision Jan 31, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    85
    Review Days
    762

    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
    MightySat -OTC
    K Number
    K214115
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Masimo Corporation
    Date Received
    December 30, 2021
    Decision Date
    January 31, 2024
    Product Code
    OLK
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OLK Pulse Oximeter For Over-The-Counter Use

    Similar 510(k) Clearances

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

    Nonin OTC Pulse Oximeter Model 3250

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

    Other Clearances by Masimo Corporation

    K Number Device Name
    K254209 Radius VSM and Accessories
    K243324 Masimo O3 Regional Oximeter
    K250757 Radius VSM and Accessories
    K243305 Masimo W1
    K240229 Masimo W1
    K234021 Masimo Stork
    K223721 Masimo Stork
    K232512 Masimo W1
    DEN200076 ORi
    K232389 Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue
    Search all 85 clearances from Masimo Corporation →