FDA 510(k)

BW685, BW685S

K-Number: K121198 · 2012-07-12

Decision Date2012-07-12

Product CodeLGZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

BW685, BW685S is the device name listed in this FDA 510(k) record. The listed applicant is Biegler GmbH. It received FDA 510(k) clearance on 2012-07-12 under 510(k) number K121198. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BW685, BW685S?

BW685, BW685S is a medical device that received FDA 510(k) clearance on 2012-07-12. The listed applicant is Biegler GmbH. The 510(k) number is K121198.

When did BW685, BW685S receive FDA 510(k) clearance?

BW685, BW685S received FDA 510(k) clearance on 2012-07-12, under 510(k) number K121198.

Who is the listed applicant for BW685, BW685S?

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

What is the FDA product code for BW685, BW685S?

The FDA product code for BW685, BW685S is LGZ.

Other records listing Biegler GmbH 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.