Swc/Dwc Warming Cabinets

FDA 510(k) K080609 · Mac Medical

Substantially Equivalent

510(k) numberK080609

Submission

Device name
Swc/Dwc Warming Cabinets
Applicant
Mac Medical
Deer Field, IL, US
Received
March 3, 2008
Decision date
June 13, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LHC – Warmer, Irrigation Solution
Device class
Class I (low risk)
Regulation
21 CFR 890.5950
Specialty
Physical Medicine

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K153713Getinge Series Warming CabinetLHC · Traditional Getinge Sourcing, LLC06/07/2016SE
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K150190IntraTemp Solution WarmerLHC · Special Ecolab, Inc.02/26/2015SE
K142173Non-Sterile ORS-400N Scope Pillow Warmer DrapeLHC · Traditional Ecolab, Inc.12/30/2014SE
K142080Non-Sterile Ors Warning Drapes/Slush+Warmer Disc-Drape/Slush+Warmer Palte-Drape /Fluid…LHC · Special Ecolab, Inc.08/28/2014SE
K083417Intratemp Solution WarmerLHC · Traditional C Change Surgical, LLC01/13/2009SE
K051819C Change Solution WarmerLHC · Traditional C Change Surgical, LLC08/15/2005SE
K0232831075LD Hush-SlushLHC · Traditional O.R. Solutions, Inc.11/13/2002SE
K023282ORS-3000LDLHC · Traditional O.R. Solutions, Inc.11/13/2002SE
K021288ORS-1000LDLHC · Traditional O.R. Solutions, Inc.06/27/2002SE

More from O.R. Solutions, Inc.

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Questions and answers

When was Swc/Dwc Warming Cabinets cleared by the FDA?

Swc/Dwc Warming Cabinets (K080609) received a 510(k) decision of Substantially Equivalent on June 13, 2008, 102 days after the submission was received.

What is the product code of K080609?

The FDA product code is LHC – Warmer, Irrigation Solution, a Class I (low risk) device regulated under 21 CFR 890.5950.