FDA 510(k)

TOMO-LINK

K-Number: K944967 · 1994-12-09

Decision Date1994-12-09

Product CodeIZF

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TOMO-LINK is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 1994-12-09 under 510(k) number K944967. The device is classified under product code IZF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOMO-LINK?

TOMO-LINK is a medical device that received FDA 510(k) clearance on 1994-12-09. The listed applicant is GE Medical Systems. The 510(k) number is K944967.

When did TOMO-LINK receive FDA 510(k) clearance?

TOMO-LINK received FDA 510(k) clearance on 1994-12-09, under 510(k) number K944967.

Who is the listed applicant for TOMO-LINK?

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

What is the FDA product code for TOMO-LINK?

The FDA product code for TOMO-LINK is IZF.

Other records listing GE Medical Systems as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.