FDA 510(k)

硬膜下電極，條/手術條，網/手術網，多條和分離網，手術映射網

K 號：K211954 · 2022-11-10

決定日期2022-11-10

產品代碼GYC

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid is the device name listed in this FDA 510(k) record. The listed applicant is Spes Medica Srl. It received FDA 510(k) clearance on 2022-11-10 under 510(k) number K211954. The device is classified under product code GYC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid?

Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Spes Medica Srl. The 510(k) number is K211954.

When did Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid receive FDA 510(k) clearance?

Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid received FDA 510(k) clearance on 2022-11-10, under 510(k) number K211954.

Who is the listed applicant for Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid?

The FDA 510(k) record lists Spes Medica Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid?

The FDA product code for Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid is GYC.

其他以 Spes Medica Srl 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K212326AC 膏 - 運導膠 K192606SAC2 - 電極膚膏 K192603Spes Medica 皮下单針電極 K190050Tech Dots - 黏貼及導電膠

相關器械（代碼：GYC）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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