FDA 510(k)

OLIZ LTB-1000A

K 號：K221189 · 2022-08-29

決定日期2022-08-29

產品代碼ILY

諮詢委員會PM

決定相當於

器材摘要

OLIZ LTB-1000A is the device name listed in this FDA 510(k) record. The listed applicant is Ltbio Co., Ltd.. It received FDA 510(k) clearance on 2022-08-29 under 510(k) number K221189. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OLIZ LTB-1000A?

OLIZ LTB-1000A is a medical device that received FDA 510(k) clearance on 2022-08-29. The listed applicant is Ltbio Co., Ltd.. The 510(k) number is K221189.

When did OLIZ LTB-1000A receive FDA 510(k) clearance?

OLIZ LTB-1000A received FDA 510(k) clearance on 2022-08-29, under 510(k) number K221189.

Who is the listed applicant for OLIZ LTB-1000A?

The FDA 510(k) record lists Ltbio Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLIZ LTB-1000A?

The FDA product code for OLIZ LTB-1000A is ILY.

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