FDA 510(k)

AC 膏 - 運導膠

K 號：K212326 · 2021-12-01

決定日期2021-12-01

產品代碼GYB

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

AC Cream - Conductive paste 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 2021-12-01 under 510(k) number K212326. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AC Cream - Conductive paste?

AC Cream - Conductive paste is a medical device that received FDA 510(k) clearance on 2021-12-01. The listed applicant is Spes Medica Srl. The 510(k) number is K212326.

When did AC Cream - Conductive paste receive FDA 510(k) clearance?

AC Cream - Conductive paste received FDA 510(k) clearance on 2021-12-01, under 510(k) number K212326.

Who is the listed applicant for AC Cream - Conductive paste?

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 AC Cream - Conductive paste?

The FDA product code for AC Cream - Conductive paste is GYB.

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。

K211954硬膜下電極，條/手術條，網/手術網，多條和分離網，手術映射網 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：GYB）

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。

K243749Jmoon 電導膠Shenzhen Ulike Smart Electronics Co., Ltd.K220735Avologi Gel Primer (型號：Av25)Premier North America, Inc.K222770導電膠Top-Rank Health Care Co., Ltd.K221724導電膠Tone-A-Matic International, Inc.K212325電腦化電腦皮層電位檢查設備Somnomedics GmbH K212787GT5 適電與磨損膠Wuhan Greentek Pty , Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。