BEUDAMED
    Product Code: JKS FDA class 1 21 CFR 862.3220

    Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide

    Clinical Toxicology

    This device is a spectral absorbance curve measurement system used to distinguish and quantify oxyhemoglobin and carboxyhemoglobin in blood specimens, supporting the diagnosis of carbon monoxide poisoning by identifying the characteristic shift in hemoglobin absorbance spectra caused by CO binding. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls with no premarket submission. The product code is JKS, regulated under 21 CFR 862.3220, within the Clinical Toxicology medical specialty.

    View on FDA
    510(k)s
    8
    FEI Numbers
    13
    Registration Numbers
    13
    Unique Applicants
    8
    Years Active
    17

    Basic Information

    Product Code
    JKS
    Device Class
    FDA class 1
    Regulation Number
    862.3220
    Medical Specialty
    Clinical Toxicology
    Review Panel
    TX
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 8 510(k) clearances via K numbers.

    K Number Device Name
    K951485 AVOXIMETER 4000
    K863825 CO-OXIMETER SOLUTIONS
    K862253 IL 482 CO-OXIMETER
    K853990 OSM3 HEMOXIMETER
    K833693 TEE ADAPTER 9890-FLUSH WINDING 282
    K833211 BILE SALTS MIXTURE
    K832066 CONTROL 282
    K780652 HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2

    FEI Numbers

    This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.