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FDA 510(k)

無線手控器，EG1A（WIRELESS-HC），無線手控器接收器，EG1A（RECEIVER-HC）

K 號：K220485 · 2022-05-19

申請人The Anspach Effort, Inc.
決定日期2022-05-19
產品代碼HBC
諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)
決定相當於

器材摘要

Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) is the device name listed in this FDA 510(k) record. The listed applicant is The Anspach Effort, Inc.. It received FDA 510(k) clearance on 2022-05-19 under 510(k) number K220485. The device is classified under product code HBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)?

Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) is a medical device that received FDA 510(k) clearance on 2022-05-19. The listed applicant is The Anspach Effort, Inc.. The 510(k) number is K220485.

When did Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) receive FDA 510(k) clearance?

Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) received FDA 510(k) clearance on 2022-05-19, under 510(k) number K220485.

Who is the listed applicant for Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)?

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

What is the FDA product code for Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)?

The FDA product code for Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) is HBC.

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