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FDA 510(k)

DSPS-Prominent™ 面罩;DSPS-Prominent™ 底板,MR;CouchStrip

K 號:K222977 · 2023-02-17

決定日期2023-02-17
產品代碼IYE
諮詢委員會RA
決定相當於

器材摘要

DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip is the device name listed in this FDA 510(k) record. The listed applicant is Macromedics BV. It received FDA 510(k) clearance on 2023-02-17 under 510(k) number K222977. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip?

DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip is a medical device that received FDA 510(k) clearance on 2023-02-17. The listed applicant is Macromedics BV. The 510(k) number is K222977.

When did DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip receive FDA 510(k) clearance?

DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip received FDA 510(k) clearance on 2023-02-17, under 510(k) number K222977.

Who is the listed applicant for DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip?

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

What is the FDA product code for DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip?

The FDA product code for DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip is IYE.

相關臨床試驗

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其他以 Macromedics BV 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。

相關器械(代碼:IYE)

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。

官方來源

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