Disposable Tm-E Cochgtrode - BLSC Part No. 101123

FDA 510(k) K944314 · Bio-Logic Systems Corp.

Substantially Equivalent

510(k) numberK944314

Submission

Device name
Disposable Tm-E Cochgtrode - BLSC Part No. 101123
Applicant
Bio-Logic Systems Corp.
Mudelein, IL, US
Received
August 29, 1994
Decision date
January 3, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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 Disposable Tm-E Cochgtrode - BLSC Part No. 101123 cleared by the FDA?

Disposable Tm-E Cochgtrode - BLSC Part No. 101123 (K944314) received a 510(k) decision of Substantially Equivalent on January 3, 1996, 492 days after the submission was received.

What is the product code of K944314?

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