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FDA 510(k)

INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II

K-Number: K012016 · 2001-07-20

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2001-07-20
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II 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 2001-07-20 under 510(k) number K012016. 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 INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II?

INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II is a medical device that received FDA 510(k) clearance on 2001-07-20. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K012016.

When did INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II receive FDA 510(k) clearance?

INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II received FDA 510(k) clearance on 2001-07-20, under 510(k) number K012016.

Who is the listed applicant for INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II?

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 SC 8000 WITH ADVANCED COMMUNICATION OPTION II?

The FDA product code for INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II is MHX.

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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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