FDA 510(k)

Anchor Bolt (comme accessoire des Electrodes de Profondeur)

Numéro K : K181544 · 2018-08-09

DemandeurAd-Tech Medical Instrument Corporation

Date de décision2018-08-09

Code produitGZL

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

Anchor Bolt (as an accessory to Depth Electrodes) is the device name listed in this FDA 510(k) record. The listed applicant is Ad-Tech Medical Instrument Corporation. It received FDA 510(k) clearance on 2018-08-09 under 510(k) number K181544. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Anchor Bolt (as an accessory to Depth Electrodes)?

Anchor Bolt (as an accessory to Depth Electrodes) is a medical device that received FDA 510(k) clearance on 2018-08-09. The listed applicant is Ad-Tech Medical Instrument Corporation. The 510(k) number is K181544.

When did Anchor Bolt (as an accessory to Depth Electrodes) receive FDA 510(k) clearance?

Anchor Bolt (as an accessory to Depth Electrodes) received FDA 510(k) clearance on 2018-08-09, under 510(k) number K181544.

Who is the listed applicant for Anchor Bolt (as an accessory to Depth Electrodes)?

The FDA 510(k) record lists Ad-Tech Medical Instrument Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anchor Bolt (as an accessory to Depth Electrodes)?

The FDA product code for Anchor Bolt (as an accessory to Depth Electrodes) is GZL.

Essais cliniques associés

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Autres dossiers indiquant Ad-Tech Medical Instrument Corporation en tant que demandeur

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Dispositifs connexes (Code : GZL)

Source officielle

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