FDA 510(k)

外科角型手持器械，外科直型手持器械

K 號：K171155 · 2017-11-21

決定日期2017-11-21

產品代碼KMW

諮詢委員會DE

決定相當於

器材摘要

Surgical Angle Handpiece, Surgical Straight Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Nakanishi, Inc.. It received FDA 510(k) clearance on 2017-11-21 under 510(k) number K171155. The device is classified under product code KMW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Surgical Angle Handpiece, Surgical Straight Handpiece?

Surgical Angle Handpiece, Surgical Straight Handpiece is a medical device that received FDA 510(k) clearance on 2017-11-21. The listed applicant is Nakanishi, Inc.. The 510(k) number is K171155.

When did Surgical Angle Handpiece, Surgical Straight Handpiece receive FDA 510(k) clearance?

Surgical Angle Handpiece, Surgical Straight Handpiece received FDA 510(k) clearance on 2017-11-21, under 510(k) number K171155.

Who is the listed applicant for Surgical Angle Handpiece, Surgical Straight Handpiece?

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

What is the FDA product code for Surgical Angle Handpiece, Surgical Straight Handpiece?

The FDA product code for Surgical Angle Handpiece, Surgical Straight Handpiece is KMW.

其他以 Nakanishi, 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。

K260773Varios Combi Pro2 K254163VarioSurg 4 K251689VARIOS 170 LUX 計量系統 (VA170LUXS10)；VARIOS 170 LUX 計量系統 (VA170LUXS11)；VARIOS 170 計量系統 (VA170S11)K252662醫療設備名稱：UniBur 醫療設備規範文本：FDA、510(k)、PMA、NCT、PMID、識別碼及網址政策：medical-regulatory-v1 翻譯結果：UniBur K241880空氣動力牙齒磨光系統（Perio-Mate）；空氣動力牙齒磨光系統（Perio Mate Nozzle Tip）K233288NLZ內置電機系統

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相關器械（代碼：KMW）

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。

K211584口腔外科對抗Nakanishi, Inc.K162544骨醫療 PINNACLE 驅動器Osteomed

官方來源

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