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FDA 510(k)

AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114 GLOVES,120-124 SOCKS,130-132 PANELS

K-Number: K023212 · 2002-12-13

ApplicantAg Garments
Decision Date2002-12-13
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114 GLOVES,120-124 SOCKS,130-132 PANELS is the device name listed in this FDA 510(k) record. The listed applicant is Ag Garments. It received FDA 510(k) clearance on 2002-12-13 under 510(k) number K023212. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114 GLOVES,120-124 SOCKS,130-132 PANELS?

AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114 GLOVES,120-124 SOCKS,130-132 PANELS is a medical device that received FDA 510(k) clearance on 2002-12-13. The listed applicant is Ag Garments. The 510(k) number is K023212.

When did AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114 GLOVES,120-124 SOCKS,130-132 PANELS receive FDA 510(k) clearance?

AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114 GLOVES,120-124 SOCKS,130-132 PANELS received FDA 510(k) clearance on 2002-12-13, under 510(k) number K023212.

Who is the listed applicant for AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114 GLOVES,120-124 SOCKS,130-132 PANELS?

The FDA 510(k) record lists Ag Garments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114 GLOVES,120-124 SOCKS,130-132 PANELS?

The FDA product code for AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114 GLOVES,120-124 SOCKS,130-132 PANELS is GXY.

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Official Source

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