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FDA 510(k)

脈搏2.0，脈搏專業版2.0

K 號：K183169 · 2018-12-27

申請人NormaTec Industries, LP
決定日期2018-12-27
產品代碼IRP
諮詢委員會PM
決定相當於

器材摘要

Pulse 2.0, Pulse Pro 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is NormaTec Industries, LP. It received FDA 510(k) clearance on 2018-12-27 under 510(k) number K183169. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pulse 2.0, Pulse Pro 2.0?

Pulse 2.0, Pulse Pro 2.0 is a medical device that received FDA 510(k) clearance on 2018-12-27. The listed applicant is NormaTec Industries, LP. The 510(k) number is K183169.

When did Pulse 2.0, Pulse Pro 2.0 receive FDA 510(k) clearance?

Pulse 2.0, Pulse Pro 2.0 received FDA 510(k) clearance on 2018-12-27, under 510(k) number K183169.

Who is the listed applicant for Pulse 2.0, Pulse Pro 2.0?

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

What is the FDA product code for Pulse 2.0, Pulse Pro 2.0?

The FDA product code for Pulse 2.0, Pulse Pro 2.0 is IRP.

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官方來源

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