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FDA 510(k)

B.U.S. ENDOTRON

K-Number: K972148 · 1997-12-10

ApplicantMedicamat S.A.
Decision Date1997-12-10
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

B.U.S. ENDOTRON is the device name listed in this FDA 510(k) record. The listed applicant is Medicamat S.A.. It received FDA 510(k) clearance on 1997-12-10 under 510(k) number K972148. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B.U.S. ENDOTRON?

B.U.S. ENDOTRON is a medical device that received FDA 510(k) clearance on 1997-12-10. The listed applicant is Medicamat S.A.. The 510(k) number is K972148.

When did B.U.S. ENDOTRON receive FDA 510(k) clearance?

B.U.S. ENDOTRON received FDA 510(k) clearance on 1997-12-10, under 510(k) number K972148.

Who is the listed applicant for B.U.S. ENDOTRON?

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

What is the FDA product code for B.U.S. ENDOTRON?

The FDA product code for B.U.S. ENDOTRON is LFL.

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 Medicamat S.A. 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.

K952737CALVITRON HAIR TRANSPLANT SYSTEM

Related Devices (Code: LFL)

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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