FDA 510(k)

規範用藥品設備名稱：SPEC 模型 M23

K 號：K161396 · 2016-08-17

申請人Source Production and Equipment Co., Inc.

決定日期2016-08-17

產品代碼KXK

諮詢委員會RA

決定相當於

器材摘要

SPEC Model M23 is the device name listed in this FDA 510(k) record. The listed applicant is Source Production and Equipment Co., Inc.. It received FDA 510(k) clearance on 2016-08-17 under 510(k) number K161396. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SPEC Model M23?

SPEC Model M23 is a medical device that received FDA 510(k) clearance on 2016-08-17. The listed applicant is Source Production and Equipment Co., Inc.. The 510(k) number is K161396.

When did SPEC Model M23 receive FDA 510(k) clearance?

SPEC Model M23 received FDA 510(k) clearance on 2016-08-17, under 510(k) number K161396.

Who is the listed applicant for SPEC Model M23?

The FDA 510(k) record lists Source Production and Equipment Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPEC Model M23?

The FDA product code for SPEC Model M23 is KXK.

其他以 Source Production and Equipment Co., 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。

K162573源生製造設備有限公司模型 M14 192Iridium 近端放射源 K161395規範用藥品名稱：SPEC 模型 M13

相關器械（代碼：KXK）

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。

K252296OncoPatchOncopatch, Inc.K242818IsoSphereIsoaid, LLC K223465RadianceTx 放射性同位素近端放射治療源Radiance Therapeutics, Inc.K221539伽馬TileGt Medical Technologies K202267Sirius MRI 標記，內含 Sirius MRI 標記的 Cs-131 預裝纖維，以 18 觀針製成Isoray Medical, Inc.K193602LV Liberty Vision 模型 1 90釔近端放射源Lv Liberty Vision Corporation

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。