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FDA 510(k)

BODYTRONIC 200

K-Number: K123921 · 2013-04-26

ApplicantBauerfeind AG
Decision Date2013-04-26
Product CodeJOM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BODYTRONIC 200 is the device name listed in this FDA 510(k) record. The listed applicant is Bauerfeind AG. It received FDA 510(k) clearance on 2013-04-26 under 510(k) number K123921. The device is classified under product code JOM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BODYTRONIC 200?

BODYTRONIC 200 is a medical device that received FDA 510(k) clearance on 2013-04-26. The listed applicant is Bauerfeind AG. The 510(k) number is K123921.

When did BODYTRONIC 200 receive FDA 510(k) clearance?

BODYTRONIC 200 received FDA 510(k) clearance on 2013-04-26, under 510(k) number K123921.

Who is the listed applicant for BODYTRONIC 200?

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

What is the FDA product code for BODYTRONIC 200?

The FDA product code for BODYTRONIC 200 is JOM.

Related Clinical Trials

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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Other records listing Bauerfeind AG 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.

K111662VENOTRAIN CURAFLOW

Related Devices (Code: JOM)

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.

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