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FDA 510(k)

DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES

K-Number: K031376 · 2003-07-16

ApplicantGe Medical Systems Information Technologies
Decision Date2003-07-16
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies. It received FDA 510(k) clearance on 2003-07-16 under 510(k) number K031376. 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 DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES?

DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES is a medical device that received FDA 510(k) clearance on 2003-07-16. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K031376.

When did DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES receive FDA 510(k) clearance?

DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES received FDA 510(k) clearance on 2003-07-16, under 510(k) number K031376.

Who is the listed applicant for DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES?

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

What is the FDA product code for DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES?

The FDA product code for DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES is MHX.

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Other records listing Ge Medical Systems Information Technologies 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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