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FDA 510(k)

DIMENSION EXL WITH LM SYSTEM

K-Number: K130276 · 2013-03-22

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2013-03-22
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIMENSION EXL WITH LM SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2013-03-22 under 510(k) number K130276. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION EXL WITH LM SYSTEM?

DIMENSION EXL WITH LM SYSTEM is a medical device that received FDA 510(k) clearance on 2013-03-22. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K130276.

When did DIMENSION EXL WITH LM SYSTEM receive FDA 510(k) clearance?

DIMENSION EXL WITH LM SYSTEM received FDA 510(k) clearance on 2013-03-22, under 510(k) number K130276.

Who is the listed applicant for DIMENSION EXL WITH LM SYSTEM?

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

What is the FDA product code for DIMENSION EXL WITH LM SYSTEM?

The FDA product code for DIMENSION EXL WITH LM SYSTEM is JJE.

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Related Devices (Code: JJE)

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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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