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FDA 510(k)

SOLAR 8000M SYSTEM

K-Number: K012467 · 2002-02-11

ApplicantGeneral Electric Medical Systems Information Techn
Decision Date2002-02-11
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOLAR 8000M SYSTEM 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 2002-02-11 under 510(k) number K012467. 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 8000M SYSTEM?

SOLAR 8000M SYSTEM is a medical device that received FDA 510(k) clearance on 2002-02-11. The listed applicant is General Electric Medical Systems Information Techn. The 510(k) number is K012467.

When did SOLAR 8000M SYSTEM receive FDA 510(k) clearance?

SOLAR 8000M SYSTEM received FDA 510(k) clearance on 2002-02-11, under 510(k) number K012467.

Who is the listed applicant for SOLAR 8000M SYSTEM?

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 8000M SYSTEM?

The FDA product code for SOLAR 8000M SYSTEM is DSI.

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Other records listing General Electric Medical Systems Information Techn as applicant

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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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