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FDA 510(k)

RELI NRFit 硬脊膜針，Phoenix NRFit 硬脊膜針，RELI NRFit 脊椎針，Phoenix NRFit 脊椎針

K 號：K203668 · 2021-09-29

申請人Myco Medical Supplies, Inc.
決定日期2021-09-29
產品代碼BSP
諮詢委員會AN
決定相當於

器材摘要

RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles is the device name listed in this FDA 510(k) record. The listed applicant is Myco Medical Supplies, Inc.. It received FDA 510(k) clearance on 2021-09-29 under 510(k) number K203668. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles?

RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles is a medical device that received FDA 510(k) clearance on 2021-09-29. The listed applicant is Myco Medical Supplies, Inc.. The 510(k) number is K203668.

When did RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles receive FDA 510(k) clearance?

RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles received FDA 510(k) clearance on 2021-09-29, under 510(k) number K203668.

Who is the listed applicant for RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles?

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

What is the FDA product code for RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles?

The FDA product code for RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles is BSP.

相關臨床試驗

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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其他以 Myco Medical Supplies, 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。

K173279RELI 安全血液採集管固定器，RELI 血液採集管固定器

相關器械（代碼：BSP）

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。

K243690SonoMSKPAJUNK GmbH MedizintechnologieK243682SonoPlex STIM；SonoPlex IIPAJUNK GmbH MedizintechnologieK250774SPROTTE® 标準 (LUER/NRFit®) 腰椎穿刺PAJUNK GmbH MedizintechnologieK243525SonoTAP 及 SonoTAP IIPAJUNK GmbH MedizintechnologieK241953SPROTTE®標準（LUER/NRFit®）麻醉學PAJUNK GmbH MedizintechnologieK241954SonoBlock；SonoBlock IIPAJUNK GmbH Medizintechnologie

官方來源

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