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FDA 510(k)

MAC 5500 HD, MAC 3500

K-Number: K110266 · 2011-04-29

ApplicantGe Medical Systems Information Technologies, Inc.
Decision Date2011-04-29
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MAC 5500 HD, MAC 3500 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 2011-04-29 under 510(k) number K110266. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAC 5500 HD, MAC 3500?

MAC 5500 HD, MAC 3500 is a medical device that received FDA 510(k) clearance on 2011-04-29. The listed applicant is Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K110266.

When did MAC 5500 HD, MAC 3500 receive FDA 510(k) clearance?

MAC 5500 HD, MAC 3500 received FDA 510(k) clearance on 2011-04-29, under 510(k) number K110266.

Who is the listed applicant for MAC 5500 HD, MAC 3500?

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 MAC 5500 HD, MAC 3500?

The FDA product code for MAC 5500 HD, MAC 3500 is DPS.

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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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