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FDA 510(k)

K-STERILE TENS ELECTRODES

K-Number: K900997 · 1990-03-13

ApplicantKatecho, Inc.
Decision Date1990-03-13
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

K-STERILE TENS ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Katecho, Inc.. It received FDA 510(k) clearance on 1990-03-13 under 510(k) number K900997. 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 K-STERILE TENS ELECTRODES?

K-STERILE TENS ELECTRODES is a medical device that received FDA 510(k) clearance on 1990-03-13. The listed applicant is Katecho, Inc.. The 510(k) number is K900997.

When did K-STERILE TENS ELECTRODES receive FDA 510(k) clearance?

K-STERILE TENS ELECTRODES received FDA 510(k) clearance on 1990-03-13, under 510(k) number K900997.

Who is the listed applicant for K-STERILE TENS ELECTRODES?

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

What is the FDA product code for K-STERILE TENS ELECTRODES?

The FDA product code for K-STERILE TENS ELECTRODES is GXY.

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Other records listing Katecho, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K012404K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85K010543KM-30 TENS ELECTRODEK003228K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70AK002806K-DEFIB/PACE, MODEL KDP-60AK000870KM-10 TENS ELECTRODEK993745K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80

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Official Source

View on FDA Database →

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