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FDA 510(k)

GE SIGNA EXCITE MR SURGICAL OPTION

K-Number: K043262 · 2005-01-12

ApplicantGE Healthcare
Decision Date2005-01-12
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GE SIGNA EXCITE MR SURGICAL OPTION is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2005-01-12 under 510(k) number K043262. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GE SIGNA EXCITE MR SURGICAL OPTION?

GE SIGNA EXCITE MR SURGICAL OPTION is a medical device that received FDA 510(k) clearance on 2005-01-12. The listed applicant is GE Healthcare. The 510(k) number is K043262.

When did GE SIGNA EXCITE MR SURGICAL OPTION receive FDA 510(k) clearance?

GE SIGNA EXCITE MR SURGICAL OPTION received FDA 510(k) clearance on 2005-01-12, under 510(k) number K043262.

Who is the listed applicant for GE SIGNA EXCITE MR SURGICAL OPTION?

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

What is the FDA product code for GE SIGNA EXCITE MR SURGICAL OPTION?

The FDA product code for GE SIGNA EXCITE MR SURGICAL OPTION is LNH.

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Other records listing GE Healthcare 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.

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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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