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FDA 510(k)

Provicol QM Plus

K-Number: K161630 · 2016-09-15

ApplicantVoco GmbH
Decision Date2016-09-15
Product CodeEMB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Provicol QM Plus is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2016-09-15 under 510(k) number K161630. The device is classified under product code EMB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Provicol QM Plus?

Provicol QM Plus is a medical device that received FDA 510(k) clearance on 2016-09-15. The listed applicant is Voco GmbH. The 510(k) number is K161630.

When did Provicol QM Plus receive FDA 510(k) clearance?

Provicol QM Plus received FDA 510(k) clearance on 2016-09-15, under 510(k) number K161630.

Who is the listed applicant for Provicol QM Plus?

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

What is the FDA product code for Provicol QM Plus?

The FDA product code for Provicol QM Plus is EMB.

Other records listing Voco 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

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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