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FDA 510(k)

OEC 9900 ELITE

K-Number: K082781 · 2009-05-01

ApplicantGe Healthcare Surgery
Decision Date2009-05-01
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OEC 9900 ELITE is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare Surgery. It received FDA 510(k) clearance on 2009-05-01 under 510(k) number K082781. 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 OEC 9900 ELITE?

OEC 9900 ELITE is a medical device that received FDA 510(k) clearance on 2009-05-01. The listed applicant is Ge Healthcare Surgery. The 510(k) number is K082781.

When did OEC 9900 ELITE receive FDA 510(k) clearance?

OEC 9900 ELITE received FDA 510(k) clearance on 2009-05-01, under 510(k) number K082781.

Who is the listed applicant for OEC 9900 ELITE?

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

What is the FDA product code for OEC 9900 ELITE?

The FDA product code for OEC 9900 ELITE is 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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