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FDA 510(k)

PHT-6500; PHT-60CFO; PAX-I3D

K-Number: K122606 · 2012-11-20

ApplicantMtechgroup
Decision Date2012-11-20
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHT-6500; PHT-60CFO; PAX-I3D is the device name listed in this FDA 510(k) record. The listed applicant is Mtechgroup. It received FDA 510(k) clearance on 2012-11-20 under 510(k) number K122606. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHT-6500; PHT-60CFO; PAX-I3D?

PHT-6500; PHT-60CFO; PAX-I3D is a medical device that received FDA 510(k) clearance on 2012-11-20. The listed applicant is Mtechgroup. The 510(k) number is K122606.

When did PHT-6500; PHT-60CFO; PAX-I3D receive FDA 510(k) clearance?

PHT-6500; PHT-60CFO; PAX-I3D received FDA 510(k) clearance on 2012-11-20, under 510(k) number K122606.

Who is the listed applicant for PHT-6500; PHT-60CFO; PAX-I3D?

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

What is the FDA product code for PHT-6500; PHT-60CFO; PAX-I3D?

The FDA product code for PHT-6500; PHT-60CFO; PAX-I3D is OAS.

Related Devices (Code: OAS)

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

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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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