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FDA 510(k)

SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO

K-Number: K031340 · 2003-11-25

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2003-11-25
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO 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 2003-11-25 under 510(k) number K031340. 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 SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO?

SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO is a medical device that received FDA 510(k) clearance on 2003-11-25. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K031340.

When did SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO receive FDA 510(k) clearance?

SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO received FDA 510(k) clearance on 2003-11-25, under 510(k) number K031340.

Who is the listed applicant for SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO?

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 SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO?

The FDA product code for SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO 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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