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FDA 510(k)

SURESIGNS VS2+ -SURESIGNS VSI

K-Number: K112652 · 2011-10-11

ApplicantPhilips Medical Systems
Decision Date2011-10-11
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SURESIGNS VS2+ -SURESIGNS VSI is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems. It received FDA 510(k) clearance on 2011-10-11 under 510(k) number K112652. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURESIGNS VS2+ -SURESIGNS VSI?

SURESIGNS VS2+ -SURESIGNS VSI is a medical device that received FDA 510(k) clearance on 2011-10-11. The listed applicant is Philips Medical Systems. The 510(k) number is K112652.

When did SURESIGNS VS2+ -SURESIGNS VSI receive FDA 510(k) clearance?

SURESIGNS VS2+ -SURESIGNS VSI received FDA 510(k) clearance on 2011-10-11, under 510(k) number K112652.

Who is the listed applicant for SURESIGNS VS2+ -SURESIGNS VSI?

The FDA 510(k) record lists Philips Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURESIGNS VS2+ -SURESIGNS VSI?

The FDA product code for SURESIGNS VS2+ -SURESIGNS VSI is DXN.

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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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