FDA 510(k)

Depth ElectrodesのアクセサリーとしてのAnchor Bolts

K番号: K223276 · 2023-05-18

申請者Ad-Tech Medical Instrument Corporation

決定日2023-05-18

製品コードGZL

諮問委員会Please provide the source text to translate.

決定大幅同等

医療機器の概要

Anchor Bolts as Accessories 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 2023-05-18 under 510(k) number K223276. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Anchor Bolts as Accessories to Depth Electrodes?

Anchor Bolts as Accessories to Depth Electrodes is a medical device that received FDA 510(k) clearance on 2023-05-18. The listed applicant is Ad-Tech Medical Instrument Corporation. The 510(k) number is K223276.

When did Anchor Bolts as Accessories to Depth Electrodes receive FDA 510(k) clearance?

Anchor Bolts as Accessories to Depth Electrodes received FDA 510(k) clearance on 2023-05-18, under 510(k) number K223276.

Who is the listed applicant for Anchor Bolts as Accessories 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 Bolts as Accessories to Depth Electrodes?

The FDA product code for Anchor Bolts as Accessories to Depth Electrodes is GZL.

申請者としてAd-Tech Medical Instrument Corporationを記載するその他の記録

K223269スペンサー・プローブ・ディープ・エレクトロード K191186硬膜下ストリップ/手術中分断電極、硬膜下グリッド/手術中グリッド電極、両側半球間硬膜下電極、多ストリップおよびスリットグリッド硬膜下電極、手術中マッピンググリッド硬膜下電極 K181544Depth ElectrodesのアクセサリーとしてのAnchor Bolt K170442頭蓋骨ドリルビットおよびアクセサリー K163355深電極、卵円孔深電極、マルコ・マイクロ深電極、スパンサープローブ深電極 K152769フレマップ電極

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