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FDA 510(k)

GE OEC ALTITUDE

K-Number: K052039 · 2005-08-11

ApplicantGe Oec Medical Systems
Decision Date2005-08-11
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GE OEC ALTITUDE is the device name listed in this FDA 510(k) record. The listed applicant is Ge Oec Medical Systems. It received FDA 510(k) clearance on 2005-08-11 under 510(k) number K052039. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GE OEC ALTITUDE?

GE OEC ALTITUDE is a medical device that received FDA 510(k) clearance on 2005-08-11. The listed applicant is Ge Oec Medical Systems. The 510(k) number is K052039.

When did GE OEC ALTITUDE receive FDA 510(k) clearance?

GE OEC ALTITUDE received FDA 510(k) clearance on 2005-08-11, under 510(k) number K052039.

Who is the listed applicant for GE OEC ALTITUDE?

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

What is the FDA product code for GE OEC ALTITUDE?

The FDA product code for GE OEC ALTITUDE is IZI.

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Other records listing Ge Oec Medical Systems as applicant

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Related Devices (Code: IZI)

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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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