FDA 510(k)

Empulse R90

K 號：K220213 · 2022-03-30

決定日期2022-03-30

產品代碼ITI

諮詢委員會PM

決定相當於

器材摘要

Empulse R90 is the device name listed in this FDA 510(k) record. The listed applicant is Sunrise Medical (Us), LLC. It received FDA 510(k) clearance on 2022-03-30 under 510(k) number K220213. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Empulse R90?

Empulse R90 is a medical device that received FDA 510(k) clearance on 2022-03-30. The listed applicant is Sunrise Medical (Us), LLC. The 510(k) number is K220213.

When did Empulse R90 receive FDA 510(k) clearance?

Empulse R90 received FDA 510(k) clearance on 2022-03-30, under 510(k) number K220213.

Who is the listed applicant for Empulse R90?

The FDA 510(k) record lists Sunrise Medical (Us), LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Empulse R90?

The FDA product code for Empulse R90 is ITI.

其他以 Sunrise Medical (Us), LLC 為申請人之記錄

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相關器械（代碼：ITI）

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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官方來源

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