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510(k) Data Aggregation
K Number
K030073Device Name
VERMED A10021 RESTING EKG TAB ELECTRODE
Manufacturer
VERMONT MEDICAL, INC.
Date Cleared
2003-03-28
(79 days)
Product Code
DRX
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
VERMONT MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vermed A10021, is designed to be a single use disposable electrode for resting EKG cardiac evaluation procedures. This electrode is designed for infant, pediatric, and adult use. The maximum duration of use is 1 hour. These electrodes should be discarded after one use on the skin.
Device Description
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K Number
K021537Device Name
MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005
Manufacturer
VERMONT MEDICAL, INC.
Date Cleared
2003-03-03
(297 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
VERMONT MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vermed A10005 electrode is designed to measure muscle activity from the surface of the skin. The A10005 can be used for Sleep Studies, surface EMG, NCS and EP.
Device Description
The Vermed A10005 electrode is designed to measure muscle activity from the surface of the skin. The A10005 electrode is provided in a NON-STERILE format only, and should be used on the surface of the skin.
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K Number
K010638Device Name
NEUROPLUS, MODEL A10040, A10041, A10042, A10043
Manufacturer
VERMONT MEDICAL, INC.
Date Cleared
2001-05-03
(59 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
VERMONT MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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