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FDA 510(k)

SOLAR 9500 INFORMATION MONITOR

K-Number: K033964 · 2004-01-15

ApplicantGe Medical Systems Information Technologies
Decision Date2004-01-15
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOLAR 9500 INFORMATION MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies. It received FDA 510(k) clearance on 2004-01-15 under 510(k) number K033964. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLAR 9500 INFORMATION MONITOR?

SOLAR 9500 INFORMATION MONITOR is a medical device that received FDA 510(k) clearance on 2004-01-15. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K033964.

When did SOLAR 9500 INFORMATION MONITOR receive FDA 510(k) clearance?

SOLAR 9500 INFORMATION MONITOR received FDA 510(k) clearance on 2004-01-15, under 510(k) number K033964.

Who is the listed applicant for SOLAR 9500 INFORMATION MONITOR?

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

What is the FDA product code for SOLAR 9500 INFORMATION MONITOR?

The FDA product code for SOLAR 9500 INFORMATION MONITOR is MHX.

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Other records listing Ge Medical Systems Information Technologies as applicant

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Related Devices (Code: MHX)

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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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