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FDA 510(k)

INFINITY MEGACARE

K-Number: K031970 · 2003-09-09

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2003-09-09
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INFINITY MEGACARE is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2003-09-09 under 510(k) number K031970. 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 INFINITY MEGACARE?

INFINITY MEGACARE is a medical device that received FDA 510(k) clearance on 2003-09-09. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K031970.

When did INFINITY MEGACARE receive FDA 510(k) clearance?

INFINITY MEGACARE received FDA 510(k) clearance on 2003-09-09, under 510(k) number K031970.

Who is the listed applicant for INFINITY MEGACARE?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFINITY MEGACARE?

The FDA product code for INFINITY MEGACARE 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.

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