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FDA 510(k)

MODIFICATION TO DASH 2500 PATIENT MONITOR

K-Number: K090702 · 2009-04-15

ApplicantGe Medical Systems Information Technologies
Decision Date2009-04-15
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO DASH 2500 PATIENT MONITOR 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 2009-04-15 under 510(k) number K090702. 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 MODIFICATION TO DASH 2500 PATIENT MONITOR?

MODIFICATION TO DASH 2500 PATIENT MONITOR is a medical device that received FDA 510(k) clearance on 2009-04-15. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K090702.

When did MODIFICATION TO DASH 2500 PATIENT MONITOR receive FDA 510(k) clearance?

MODIFICATION TO DASH 2500 PATIENT MONITOR received FDA 510(k) clearance on 2009-04-15, under 510(k) number K090702.

Who is the listed applicant for MODIFICATION TO DASH 2500 PATIENT MONITOR?

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 MODIFICATION TO DASH 2500 PATIENT MONITOR?

The FDA product code for MODIFICATION TO DASH 2500 PATIENT MONITOR is MHX.

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Other records listing Ge Medical Systems Information Technologies as applicant

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Related Devices (Code: MHX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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