FDA 510(k)

Coolief 開放式射頻產生器系統 (CRG)

K 號：K192491 · 2020-02-21

決定日期2020-02-21

產品代碼GXD

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

Coolief Radiofrequency Generator (CRG) System is the device name listed in this FDA 510(k) record. The listed applicant is Avanos Medical, Inc.. It received FDA 510(k) clearance on 2020-02-21 under 510(k) number K192491. The device is classified under product code GXD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Coolief Radiofrequency Generator (CRG) System?

Coolief Radiofrequency Generator (CRG) System is a medical device that received FDA 510(k) clearance on 2020-02-21. The listed applicant is Avanos Medical, Inc.. The 510(k) number is K192491.

When did Coolief Radiofrequency Generator (CRG) System receive FDA 510(k) clearance?

Coolief Radiofrequency Generator (CRG) System received FDA 510(k) clearance on 2020-02-21, under 510(k) number K192491.

Who is the listed applicant for Coolief Radiofrequency Generator (CRG) System?

The FDA 510(k) record lists Avanos Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Coolief Radiofrequency Generator (CRG) System?

The FDA product code for Coolief Radiofrequency Generator (CRG) System is GXD.

其他以 Avanos Medical, Inc. 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。

K243572Game Ready系統（550500-04）；Game Ready控制單元（550550-04）；Game Ready全腿靴包-中號（590923-04）；Game Ready全腿靴包-大號（590922-04）；Game Ready C-T脊椎包（590502-04）；Game Ready半腿靴（590906-04）；Game Ready背部包（590500-04）；Game Ready手/手腕包（590811-04）；Game Ready彎曲肘包（590903-04）；Game Ready直肘包（590200-04）；Game Ready肩膀包，中號，右邊（590422-04）；Game Ready肩膀包，La K241185CORGRIP* SR NG/NI 管道固定系統 K242057COOLIEF* 電頻發生器 (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)K240965CORTRAK* 2 腹腔內進入系統 (20-0950)K220588Avanos* CORTRAK* 2 腸道進入系統 (EAS)K203066COOLIEF 冷卻式電波刀組高級版

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相關器械（代碼：GXD）

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。

K251247GX1 電波頻率發生器套件 (RFG-X1-120V)；GX1 電波頻率發生器套件 (RFG-X1-220V)；GX1 電波頻率發生器套件 (RFG-X1-240V)；GX1 系統全球發布 (GX1-SYS-ROW)；GX1 電波頻率發生器 (51779845-01)；GX1 電波頻率發生器 (51779845-02)；GX1 電波頻率發生器 (51779845-03)Boston Scientific Neuromodulation Corporation K242057COOLIEF* 電頻發生器 (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)Avanos Medical, Inc.K232632拉茲神經統計RF發生器Epimed International K231675OneRF 消融系統Neuroone Medical Technologies Corp.K220122APEX 6Rf Innovations, Inc.K203293Abbott 医療 Grounding Pad, 型號 RF-DGP-ISABBOTT MEDICAL

官方來源

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