FDA 510(k)

C-beam

K 號：K252735 · 2026-05-22

決定日期2026-05-22

產品代碼OWB

諮詢委員會RA

決定相當於

器材摘要

C-beam is the device name listed in this FDA 510(k) record. The listed applicant is Pulmera, Inc.. It received FDA 510(k) clearance on 2026-05-22 under 510(k) number K252735. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the C-beam?

C-beam is a medical device that received FDA 510(k) clearance on 2026-05-22. The listed applicant is Pulmera, Inc.. The 510(k) number is K252735.

When did C-beam receive FDA 510(k) clearance?

C-beam received FDA 510(k) clearance on 2026-05-22, under 510(k) number K252735.

Who is the listed applicant for C-beam?

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

What is the FDA product code for C-beam?

The FDA product code for C-beam is OWB.

相關器械（代碼：OWB）

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官方來源

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