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FDA 510(k)

LOFRIC SENSE

K-Number: K123751 · 2013-02-28

ApplicantWellspect Healthcare
Decision Date2013-02-28
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LOFRIC SENSE is the device name listed in this FDA 510(k) record. The listed applicant is Wellspect Healthcare. It received FDA 510(k) clearance on 2013-02-28 under 510(k) number K123751. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOFRIC SENSE?

LOFRIC SENSE is a medical device that received FDA 510(k) clearance on 2013-02-28. The listed applicant is Wellspect Healthcare. The 510(k) number is K123751.

When did LOFRIC SENSE receive FDA 510(k) clearance?

LOFRIC SENSE received FDA 510(k) clearance on 2013-02-28, under 510(k) number K123751.

Who is the listed applicant for LOFRIC SENSE?

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

What is the FDA product code for LOFRIC SENSE?

The FDA product code for LOFRIC SENSE is EZD.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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