FDA 510(k)

BC PLUS

K-Number: K043562 · 2005-01-03

Decision Date2005-01-03

Product CodeKLE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

BC PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Vericom Co., Ltd.. It received FDA 510(k) clearance on 2005-01-03 under 510(k) number K043562. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BC PLUS?

BC PLUS is a medical device that received FDA 510(k) clearance on 2005-01-03. The listed applicant is Vericom Co., Ltd.. The 510(k) number is K043562.

When did BC PLUS receive FDA 510(k) clearance?

BC PLUS received FDA 510(k) clearance on 2005-01-03, under 510(k) number K043562.

Who is the listed applicant for BC PLUS?

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

What is the FDA product code for BC PLUS?

The FDA product code for BC PLUS is KLE.

Other records listing Vericom Co., Ltd. as applicant

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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.