Acrylic Herbst Appliance with Micro-Recorder
K 號：K170606 · 2017-11-16
廣告
器材摘要
Acrylic Herbst Appliance with Micro-Recorder is the device name listed in this FDA 510(k) record. The listed applicant is Gergen'S Orthodontic Lab. It received FDA 510(k) clearance on 2017-11-16 under 510(k) number K170606. The device is classified under product code PLC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Acrylic Herbst Appliance with Micro-Recorder?
Acrylic Herbst Appliance with Micro-Recorder is a medical device that received FDA 510(k) clearance on 2017-11-16. The listed applicant is Gergen'S Orthodontic Lab. The 510(k) number is K170606.
When did Acrylic Herbst Appliance with Micro-Recorder receive FDA 510(k) clearance?
Acrylic Herbst Appliance with Micro-Recorder received FDA 510(k) clearance on 2017-11-16, under 510(k) number K170606.
Who is the listed applicant for Acrylic Herbst Appliance with Micro-Recorder?
The FDA 510(k) record lists Gergen'S Orthodontic Lab as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Acrylic Herbst Appliance with Micro-Recorder?
The FDA product code for Acrylic Herbst Appliance with Micro-Recorder is PLC.
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。
相關器械（代碼：PLC）
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。
K254304iNOS口腔生物感測器Achaemenid, LLCK252765ProSomnus RPMO2 OSA 裝置（RPMO2 OSA）Prosomnus Sleep TechnologiesK233497安心系統Somnomed, Inc.K190353Bfit Sleep，Bfit Sleep 配 DentiTrac，Bfit Engage，Bfit Engage 配 DentiTracResidential Home Sleep ServicesK181571OASYS 口腔/鼻腔氣道系統及 OASYS Herbst 配戴 Dentitrac 患者監護器Mark Abramson, D.D.S., Inc.K172859Prosomnus [CA] 睡眠和打鼾設備以及帶有微型錄音器的Prosomnus [CA] 睡眠和打鼾設備Prosomnous Sleep Technologies
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。
廣告