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FDA 510(k)

ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes

K-Number: K152522 · 2016-01-15

ApplicantEcolab, Inc.
Decision Date2016-01-15
Product CodeLHC
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes is a medical device manufactured by Ecolab, Inc.. It received FDA 510(k) clearance on 2016-01-15 under approval number K152522. The device is classified under product code LHC. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes?

ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes is a medical device that received FDA 510(k) clearance on 2016-01-15. It is manufactured by Ecolab, Inc.. The 510(k) number is K152522.

When was ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes approved by the FDA?

ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes received FDA 510(k) clearance on 2016-01-15, under approval number K152522.

What company makes ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes?

ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes is manufactured by Ecolab, Inc..

What is the FDA product code for ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes?

The FDA product code for ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes is LHC.

Related Clinical Trials

Other Devices by Ecolab, Inc.

Related Devices (Code: LHC)

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.