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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 the device name listed in this FDA 510(k) record. The listed applicant is Ecolab, Inc.. It received FDA 510(k) clearance on 2016-01-15 under 510(k) 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. The listed applicant is Ecolab, Inc.. The 510(k) number is K152522.

When did ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes receive FDA 510(k) clearance?

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

Who is the listed applicant for ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes?

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

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.

Other records listing Ecolab, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182164Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower WandK173164Ecolab POU Water Filter

Related Devices (Code: LHC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K153713Getinge Series Warming CabinetGetinge Sourcing, LLC

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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