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FDA 510(k)

MAIA, MODEL 1

K-Number: K092187 · 2010-05-27

ApplicantCentervue S.P.A.
Decision Date2010-05-27
Product CodeHPT
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MAIA, MODEL 1 is the device name listed in this FDA 510(k) record. The listed applicant is Centervue S.P.A.. It received FDA 510(k) clearance on 2010-05-27 under 510(k) number K092187. The device is classified under product code HPT. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAIA, MODEL 1?

MAIA, MODEL 1 is a medical device that received FDA 510(k) clearance on 2010-05-27. The listed applicant is Centervue S.P.A.. The 510(k) number is K092187.

When did MAIA, MODEL 1 receive FDA 510(k) clearance?

MAIA, MODEL 1 received FDA 510(k) clearance on 2010-05-27, under 510(k) number K092187.

Who is the listed applicant for MAIA, MODEL 1?

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

What is the FDA product code for MAIA, MODEL 1?

The FDA product code for MAIA, MODEL 1 is HPT.

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Other records listing Centervue S.P.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.

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Related Devices (Code: HPT)

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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