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FDA 510(k)

OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME

K-Number: K123603 · 2013-05-17

ApplicantGe Healthcare Surgery GE Oec Medical Systems, Inc.
Decision Date2013-05-17
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare Surgery GE Oec Medical Systems, Inc.. It received FDA 510(k) clearance on 2013-05-17 under 510(k) number K123603. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME?

OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME is a medical device that received FDA 510(k) clearance on 2013-05-17. The listed applicant is Ge Healthcare Surgery GE Oec Medical Systems, Inc.. The 510(k) number is K123603.

When did OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME receive FDA 510(k) clearance?

OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME received FDA 510(k) clearance on 2013-05-17, under 510(k) number K123603.

Who is the listed applicant for OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME?

The FDA 510(k) record lists Ge Healthcare Surgery 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 BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME?

The FDA product code for OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME is OXO.

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

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.

K122234OEC 9900 ELITEK120613OEC 9900 ELITE

Related Devices (Code: OXO)

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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