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FDA 510(k)

SOLAR 7/8000

K-Number: K993757 · 2000-03-23

ApplicantGeneral Electric Medical Systems Information Techn
Decision Date2000-03-23
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOLAR 7/8000 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 2000-03-23 under 510(k) number K993757. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLAR 7/8000?

SOLAR 7/8000 is a medical device that received FDA 510(k) clearance on 2000-03-23. The listed applicant is General Electric Medical Systems Information Techn. The 510(k) number is K993757.

When did SOLAR 7/8000 receive FDA 510(k) clearance?

SOLAR 7/8000 received FDA 510(k) clearance on 2000-03-23, under 510(k) number K993757.

Who is the listed applicant for SOLAR 7/8000?

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 7/8000?

The FDA product code for SOLAR 7/8000 is DSI.

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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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