Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K103637
    Device Name
    ERKA. PERFECT-ANEROID
    Date Cleared
    2011-06-08

    (177 days)

    Product Code
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    ERKA KALLMEYER MEDIZINTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ERKA. Perfect-Aneroid sphygmomanometer is intended for the non-invasive blood pressure measurement of adult and paediatric, but not neonatal patients. The device is not designed, sold or intended for use except as indicated.
    Device Description
    The ERKA. Perfect-Aneroid Sphygmomanometer is an established manual noninvasive blood pressure measurement device that facilitates the auscultatory measuring method of Riva Rocci / Korotkoff. The ERKA. Perfect-Aneroid Sphyqmomanometer is designed to non-invasively measure the systolic and diastolic blood pressure of adult and paediatric, but not neonatal patients together with a common stethoscope. The ERKA. Perfect-Aneroid Sphygmomanometer contains the following components: - the manometer consisting of the main body, gauge, valve, bulb and spoon and - the cuff consisting of cover, bladder and tubing. The ERKA. Perfect-Aneroid comes in two model types: As Model ERKA. Perfect-Aneroid 48, with a 48mm scale diameter scale and as ERKA. Perfect-Aneroid 56, with a 56mm scale diameter. Both types differ solely in the size of the scale. The larger scale allows an easier reading, e.g. for users with reduced eyesight. The smaller 48mm device realizes a weight advantage while ensuring equal precision and functionalitv. The ERKA. Perfect-Aneroid gauge works with a traditional gear driven pointer movement that is triggered by pressure induction on a sealed membrane. The manometer features a brass chrome plated housing and a membrane protecting 2tube technology. The mechanics function in exactly the same way in both diameter sizes. The device comes with a polyurethane coated wipeable cuff. The duo-tubing is made of latex-free silicone and the inflatable bladder in the cuff is made of polyurethane material. The cuffs meet the required biocompatibility standards and are substantially equivalent to the cuffs marketed under 510(k) clearance K071885 and K001333. The cuffs may be obtained in the following sizes: - Pediatric: Limb circumference 14 cm 21.5 cm - Small adult: Limb circumference 20.5 cm 28 cm - Adult: Limb circumference 27 cm 35 cm - Large Adult: Limb circumference 34 cm 43 cm - Thigh: Limb circumference 42 cm 54 cm 54 cm '
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1