Nortech Model 87202204 Electrode

FDA 510(k) K903554 · Medtronic Andover Medical, Inc.

Substantially Equivalent

510(k) numberK903554

Submission

Device name
Nortech Model 87202204 Electrode
Applicant
Medtronic Andover Medical, Inc.
Haverhill, MA, US
Received
August 7, 1990
Decision date
August 30, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GXY – Electrode, Cutaneous
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1320
Specialty
Neurology

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Questions and answers

When was Nortech Model 87202204 Electrode cleared by the FDA?

Nortech Model 87202204 Electrode (K903554) received a 510(k) decision of Substantially Equivalent on August 30, 1990, 23 days after the submission was received.

What is the product code of K903554?

The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.