FDA 510(k)

MARS HOLTER ANALYSIS WORKSTATION

K-Number: K132437 · 2013-12-04

ApplicantGe Medical Systems Information Technologies, Inc.

Decision Date2013-12-04

Product CodeDQK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MARS HOLTER ANALYSIS WORKSTATION is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies, Inc.. It received FDA 510(k) clearance on 2013-12-04 under 510(k) number K132437. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MARS HOLTER ANALYSIS WORKSTATION?

MARS HOLTER ANALYSIS WORKSTATION is a medical device that received FDA 510(k) clearance on 2013-12-04. The listed applicant is Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K132437.

When did MARS HOLTER ANALYSIS WORKSTATION receive FDA 510(k) clearance?

MARS HOLTER ANALYSIS WORKSTATION received FDA 510(k) clearance on 2013-12-04, under 510(k) number K132437.

Who is the listed applicant for MARS HOLTER ANALYSIS WORKSTATION?

The FDA 510(k) record lists Ge Medical Systems Information Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MARS HOLTER ANALYSIS WORKSTATION?

The FDA product code for MARS HOLTER ANALYSIS WORKSTATION is DQK.

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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.