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510(k) Data Aggregation
K Number
K203494Device Name
Nissha Medical Technologies Neutral Electrodes
Manufacturer
Date Cleared
2021-02-23
(88 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Nissha Medical Technologies LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Nissha Medical Technologies Neutral Electrodes - SWAROPLATE:
Neutral electrodes are an accessory for monopolar HF-surgery and represent the large area and low impedance contact with the patient's skin required for returning the electric current to the HF-generator. Neutral electrodes are self-adhesive, ready-to-use disposable products.
The SWAROPLATE neutral electrodes of Nissha Medical Technologies are not intended for use in High Current Mode. These are applications with high current and / or long activation periods where heating factors of more than 30 A²s in a 60 s period occur.
Nissha Medical Technologies Neutral Electrodes - Boston Scientific:
Neutral electrodes are an accessory for monopolar HF-surgery and represent the large area and low impedance contact with the patient's skin required for returning the electric current to the HF-generator. Neutral electrodes are self-adhesive, ready-to-use disposable products.
The Boston Scientific Neutral Electrodes REF DGP-PMC2-5, REF DGP-PMC2-25, REF DGP-PM2-5, and REF DGP-PM2-25 are intended to be used in combination with the devices "Boston Scientific G4TM and 1A/1B Radiofrequency Generators".
Device Description
A neutral electrode is a non-sterile non-active dispersive conductor intended to be fastened to a patient and connected to an electrosurgical diathermy generator, to create a circuit for the return of electrical current to the generator after its emission to perform electrosurgery on the patient. It is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It may or may not include a return cable(s). This medical device is intended for single-use.
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