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FDA 510(k)

GE PRECISION MPI

K-Number: K033486 · 2003-11-19

ApplicantNrt-Nordisk Rontgen Teknik A/S
Decision Date2003-11-19
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GE PRECISION MPI is the device name listed in this FDA 510(k) record. The listed applicant is Nrt-Nordisk Rontgen Teknik A/S. It received FDA 510(k) clearance on 2003-11-19 under 510(k) number K033486. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GE PRECISION MPI?

GE PRECISION MPI is a medical device that received FDA 510(k) clearance on 2003-11-19. The listed applicant is Nrt-Nordisk Rontgen Teknik A/S. The 510(k) number is K033486.

When did GE PRECISION MPI receive FDA 510(k) clearance?

GE PRECISION MPI received FDA 510(k) clearance on 2003-11-19, under 510(k) number K033486.

Who is the listed applicant for GE PRECISION MPI?

The FDA 510(k) record lists Nrt-Nordisk Rontgen Teknik A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GE PRECISION MPI?

The FDA product code for GE PRECISION MPI is OWB.

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Related Devices (Code: OWB)

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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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