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FDA 510(k)

TCM 3000 AND TCM ENDO

K-Number: K981679 · 1999-02-09

ApplicantNOUVAG AG
Decision Date1999-02-09
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TCM 3000 AND TCM ENDO is the device name listed in this FDA 510(k) record. The listed applicant is NOUVAG AG. It received FDA 510(k) clearance on 1999-02-09 under 510(k) number K981679. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TCM 3000 AND TCM ENDO?

TCM 3000 AND TCM ENDO is a medical device that received FDA 510(k) clearance on 1999-02-09. The listed applicant is NOUVAG AG. The 510(k) number is K981679.

When did TCM 3000 AND TCM ENDO receive FDA 510(k) clearance?

TCM 3000 AND TCM ENDO received FDA 510(k) clearance on 1999-02-09, under 510(k) number K981679.

Who is the listed applicant for TCM 3000 AND TCM ENDO?

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

What is the FDA product code for TCM 3000 AND TCM ENDO?

The FDA product code for TCM 3000 AND TCM ENDO is EFB.

Other records listing NOUVAG 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.

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Related Devices (Code: EFB)

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

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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