FDA 510(k)

A-Line Advanced

K-Number: K231635 · 2023-06-06

Decision Date2023-06-06

Product CodeNJM

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

A-Line Advanced is the device name listed in this FDA 510(k) record. The listed applicant is Biocetec Co., Ltd.. It received FDA 510(k) clearance on 2023-06-06 under 510(k) number K231635. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A-Line Advanced?

A-Line Advanced is a medical device that received FDA 510(k) clearance on 2023-06-06. The listed applicant is Biocetec Co., Ltd.. The 510(k) number is K231635.

When did A-Line Advanced receive FDA 510(k) clearance?

A-Line Advanced received FDA 510(k) clearance on 2023-06-06, under 510(k) number K231635.

Who is the listed applicant for A-Line Advanced?

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

What is the FDA product code for A-Line Advanced?

The FDA product code for A-Line Advanced is NJM.

Other records listing Biocetec Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.