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FDA 510(k)

TRAM 2001 MODULE

K-Number: K011000 · 2001-06-29

ApplicantGeneral Electric Medical Systems Information Techn
Decision Date2001-06-29
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRAM 2001 MODULE 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 2001-06-29 under 510(k) number K011000. 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 TRAM 2001 MODULE?

TRAM 2001 MODULE is a medical device that received FDA 510(k) clearance on 2001-06-29. The listed applicant is General Electric Medical Systems Information Techn. The 510(k) number is K011000.

When did TRAM 2001 MODULE receive FDA 510(k) clearance?

TRAM 2001 MODULE received FDA 510(k) clearance on 2001-06-29, under 510(k) number K011000.

Who is the listed applicant for TRAM 2001 MODULE?

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 TRAM 2001 MODULE?

The FDA product code for TRAM 2001 MODULE is MHX.

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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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