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FDA 510(k)

OEC(R) 9800, OEC(R) 9800 PLUS

K-Number: K111551 · 2011-10-04

ApplicantGe Oec Medical Systems, Inc.
Decision Date2011-10-04
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OEC(R) 9800, OEC(R) 9800 PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Ge Oec Medical Systems, Inc.. It received FDA 510(k) clearance on 2011-10-04 under 510(k) number K111551. 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(R) 9800, OEC(R) 9800 PLUS?

OEC(R) 9800, OEC(R) 9800 PLUS is a medical device that received FDA 510(k) clearance on 2011-10-04. The listed applicant is Ge Oec Medical Systems, Inc.. The 510(k) number is K111551.

When did OEC(R) 9800, OEC(R) 9800 PLUS receive FDA 510(k) clearance?

OEC(R) 9800, OEC(R) 9800 PLUS received FDA 510(k) clearance on 2011-10-04, under 510(k) number K111551.

Who is the listed applicant for OEC(R) 9800, OEC(R) 9800 PLUS?

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

What is the FDA product code for OEC(R) 9800, OEC(R) 9800 PLUS?

The FDA product code for OEC(R) 9800, OEC(R) 9800 PLUS is OWB.

Other records listing Ge Oec Medical Systems, Inc. as applicant

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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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