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FDA 510(k)

SENSIS, SENSIS LITE

K-Number: K131812 · 2013-07-25

ApplicantSiemens Medi Cal Solutions, Inc.
Decision Date2013-07-25
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SENSIS, SENSIS LITE is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medi Cal Solutions, Inc.. It received FDA 510(k) clearance on 2013-07-25 under 510(k) number K131812. 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 SENSIS, SENSIS LITE?

SENSIS, SENSIS LITE is a medical device that received FDA 510(k) clearance on 2013-07-25. The listed applicant is Siemens Medi Cal Solutions, Inc.. The 510(k) number is K131812.

When did SENSIS, SENSIS LITE receive FDA 510(k) clearance?

SENSIS, SENSIS LITE received FDA 510(k) clearance on 2013-07-25, under 510(k) number K131812.

Who is the listed applicant for SENSIS, SENSIS LITE?

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

What is the FDA product code for SENSIS, SENSIS LITE?

The FDA product code for SENSIS, SENSIS LITE 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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