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FDA 510(k)

MD 10, SEM, SM 12, CBM

K-Number: K000710 · 2000-05-11

ApplicantNOUVAG AG
Decision Date2000-05-11
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MD 10, SEM, SM 12, CBM is the device name listed in this FDA 510(k) record. The listed applicant is NOUVAG AG. It received FDA 510(k) clearance on 2000-05-11 under 510(k) number K000710. 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 MD 10, SEM, SM 12, CBM?

MD 10, SEM, SM 12, CBM is a medical device that received FDA 510(k) clearance on 2000-05-11. The listed applicant is NOUVAG AG. The 510(k) number is K000710.

When did MD 10, SEM, SM 12, CBM receive FDA 510(k) clearance?

MD 10, SEM, SM 12, CBM received FDA 510(k) clearance on 2000-05-11, under 510(k) number K000710.

Who is the listed applicant for MD 10, SEM, SM 12, CBM?

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 MD 10, SEM, SM 12, CBM?

The FDA product code for MD 10, SEM, SM 12, CBM 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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