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FDA 510(k)

SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM

K-Number: K992135 · 1999-09-08

ApplicantGe Medical Systems, Inc.
Decision Date1999-09-08
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, Inc.. It received FDA 510(k) clearance on 1999-09-08 under 510(k) number K992135. 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 SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM?

SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM is a medical device that received FDA 510(k) clearance on 1999-09-08. The listed applicant is Ge Medical Systems, Inc.. The 510(k) number is K992135.

When did SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM receive FDA 510(k) clearance?

SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM received FDA 510(k) clearance on 1999-09-08, under 510(k) number K992135.

Who is the listed applicant for SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM?

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

What is the FDA product code for SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM?

The FDA product code for SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM is LNH.

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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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