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FDA 510(k)

BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX

K-Number: K103476 · 2011-06-16

ApplicantGe Medical Systems, LLC
Decision Date2011-06-16
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2011-06-16 under 510(k) number K103476. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX?

BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX is a medical device that received FDA 510(k) clearance on 2011-06-16. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K103476.

When did BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX receive FDA 510(k) clearance?

BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX received FDA 510(k) clearance on 2011-06-16, under 510(k) number K103476.

Who is the listed applicant for BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX?

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

What is the FDA product code for BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX?

The FDA product code for BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX is IZL.

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Related Devices (Code: IZL)

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

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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