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510(k) Data Aggregation
K Number
K024264Device Name
SKINTACT
Manufacturer
LEONHARD LANG CO.
Date Cleared
2003-01-16
(24 days)
Product Code
DRX
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
LEONHARD LANG CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Skintact ECG electrodes are designed for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include in particular patient ECG surveillance and ECG diagnosis recording. Skintact ECG electrodes are non-sterile and are to be used on intact (uninjured) skin.
Device Description
Skintact® ECG Electrodes (and as also to be offered for sale under various private label tradenames) will be offered with KS 01 solid wet gel. Just like the OR liguid gel electrodes, KS 01 solid wet gel electrodes are self-adhesive, non-sterile, single use disposable snap electrodes. The KS 01 solid wet gel electrodes are identical in size, shape and configuration to the QR liquid gel Skintact ECG electrodes currently marketed by Leonhard Lang, GmbH. All electrode configurations include a stainless steel stud to guarantee an unimpaired performance during the shelf-life of the product. All electrodes include an ABS sensor element coated with silver. The silver layer is either completely or partially (in the areas in contact with the conductive gel) covered with a silver chloride layer. This is the same construction as the current Skintact® ECG electrode using OR liguid gel conducting media.
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K Number
K982521Device Name
SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES
Manufacturer
LEONHARD LANG CO.
Date Cleared
1999-10-26
(463 days)
Product Code
DRX
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
LEONHARD LANG CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Skintact ECG electrodes are designed for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include in particular patient ECG surveillance and ECG diagnosis recordings. Skintact ECG electrodes are non-sterile and are to be used on intact (uninjured) skin.
Device Description
Skintact ECG electrodes are self-adhesive, non-sterile, single use disposable ECG electrodes. All include a silver/silver chloride sensing element, a stainless steel stud and a conductive gel. These conductive elements are held in place on the patient's skin by a carrier tape coated with a pressure sensitive medical qrade adhesive.
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