CUEVA CRANIAL NERVE ELECTRODE— 510(k) K944061

Clearance details

Applicant

Ad-Tech Medical Instrument Corp

Product code

Code GZL

Device class

Class 2

Regulation

21 CFR 882.1330

Advisory panel

Neurology

Date received

1994-08-19

Decision date

1995-01-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Racine, WI, US

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• Z-0106-2015 — Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-3X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX. Box Label: 2 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-2KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-2X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX.Class II·Terminated·Ad-Tech Medical Instrument Corporation·20141008

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K944061.