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FDA 510(k)

TECA NCS ELECTRODE SYSTEM 2000

K-Number: K971914 · 1998-03-26

ApplicantMedelec, Inc. D.B.A. Teca Corp.
Decision Date1998-03-26
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TECA NCS ELECTRODE SYSTEM 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Medelec, Inc. D.B.A. Teca Corp.. It received FDA 510(k) clearance on 1998-03-26 under 510(k) number K971914. 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 TECA NCS ELECTRODE SYSTEM 2000?

TECA NCS ELECTRODE SYSTEM 2000 is a medical device that received FDA 510(k) clearance on 1998-03-26. The listed applicant is Medelec, Inc. D.B.A. Teca Corp.. The 510(k) number is K971914.

When did TECA NCS ELECTRODE SYSTEM 2000 receive FDA 510(k) clearance?

TECA NCS ELECTRODE SYSTEM 2000 received FDA 510(k) clearance on 1998-03-26, under 510(k) number K971914.

Who is the listed applicant for TECA NCS ELECTRODE SYSTEM 2000?

The FDA 510(k) record lists Medelec, Inc. D.B.A. Teca Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TECA NCS ELECTRODE SYSTEM 2000?

The FDA product code for TECA NCS ELECTRODE SYSTEM 2000 is GXY.

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Other records listing Medelec, Inc. D.B.A. Teca Corp. 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.

K973442TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODESK973444TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES

Related Devices (Code: GXY)

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Official Source

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