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FDA 510(k)

CUATTRO UNOMD

K-Number: K093480 · 2010-03-05

ApplicantCuattro, LLC
Decision Date2010-03-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CUATTRO UNOMD is the device name listed in this FDA 510(k) record. The listed applicant is Cuattro, LLC. It received FDA 510(k) clearance on 2010-03-05 under 510(k) number K093480. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUATTRO UNOMD?

CUATTRO UNOMD is a medical device that received FDA 510(k) clearance on 2010-03-05. The listed applicant is Cuattro, LLC. The 510(k) number is K093480.

When did CUATTRO UNOMD receive FDA 510(k) clearance?

CUATTRO UNOMD received FDA 510(k) clearance on 2010-03-05, under 510(k) number K093480.

Who is the listed applicant for CUATTRO UNOMD?

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

What is the FDA product code for CUATTRO UNOMD?

The FDA product code for CUATTRO UNOMD is LLZ.

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Other records listing Cuattro, LLC 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.

K161937CuattroDR

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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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