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FDA 510(k)

SOLAR 9500 INFORMATION MONITOR

K-Number: K990068 · 1999-07-14

ApplicantGeneral Electric Medical Systems Information Techn
Decision Date1999-07-14
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 General Electric Medical Systems Information Techn. It received FDA 510(k) clearance on 1999-07-14 under 510(k) number K990068. 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 1999-07-14. The listed applicant is General Electric Medical Systems Information Techn. The 510(k) number is K990068.

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

SOLAR 9500 INFORMATION MONITOR received FDA 510(k) clearance on 1999-07-14, under 510(k) number K990068.

Who is the listed applicant for SOLAR 9500 INFORMATION MONITOR?

The FDA 510(k) record lists General Electric Medical Systems Information Techn 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 General Electric Medical Systems Information Techn 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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