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510(k) Data Aggregation
K Number
K022909Device Name
NIKOMED TRACE 1 ECG ELECTRODES
Manufacturer
NIKOMED U.S.A., INC.
Date Cleared
2003-01-09
(128 days)
Product Code
DRX
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
NIKOMED U.S.A., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nikomed TRACE 1™ ECG Electrode is indicated for use on the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram. (CFR 870.2360)
Device Description
The ECG electrode labels will have the TRACE 1™ name and will use pictographic instructions for use. This change applies to all currently marketed and any previously cleared (via premarket-notification) electrodes sold or distributed by NIKOMED USA, Inc.
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K Number
K000079Device Name
NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M
Manufacturer
NIKOMED U.S.A., INC.
Date Cleared
2000-02-04
(24 days)
Product Code
HAM
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
NIKOMED U.S.A., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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