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FDA 510(k)

A-Line Advanced

K-Number: K231635 · 2023-06-06

ApplicantBiocetec Co., Ltd.
Decision Date2023-06-06
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

A-Line Advanced is a medical device manufactured by Biocetec Co., Ltd.. It received FDA 510(k) clearance on 2023-06-06 under approval 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. It is manufactured by Biocetec Co., Ltd.. The 510(k) number is K231635.

When was A-Line Advanced approved by the FDA?

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

What company makes A-Line Advanced?

A-Line Advanced is manufactured by Biocetec Co., Ltd..

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

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

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Official Source

View on FDA Database →

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

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