Non-Sterile Ors Warning Drapes/Slush+Warmer Disc-Drape/Slush+Warmer Palte-Drape /Fluid Warmer Drape,Skirted
FDA 510(k) K142080 · Ecolab, Inc.
510(k) numberK142080
Submission
- Device name
- Non-Sterile Ors Warning Drapes/Slush+Warmer Disc-Drape/Slush+Warmer Palte-Drape /Fluid Warmer Drape,Skirted
- Applicant
- Ecolab, Inc.
Saint Paul, MN, US - Received
- July 31, 2014
- Decision date
- August 28, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LHC – Warmer, Irrigation Solution
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5950
- Specialty
- Physical Medicine
Other 510(k)s with product code LHC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K153713 | Getinge Series Warming CabinetLHC · Traditional | Getinge Sourcing, LLC | 06/07/2016SE |
| K152522 | ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming DrapesLHC · Special | Ecolab, Inc. | 01/15/2016SE |
| K150190 | IntraTemp Solution WarmerLHC · Special | Ecolab, Inc. | 02/26/2015SE |
| K142173 | Non-Sterile ORS-400N Scope Pillow Warmer DrapeLHC · Traditional | Ecolab, Inc. | 12/30/2014SE |
| K083417 | Intratemp Solution WarmerLHC · Traditional | C Change Surgical, LLC | 01/13/2009SE |
| K080609 | Swc/Dwc Warming CabinetsLHC · Traditional | Mac Medical | 06/13/2008SE |
| K051819 | C Change Solution WarmerLHC · Traditional | C Change Surgical, LLC | 08/15/2005SE |
| K023283 | 1075LD Hush-SlushLHC · Traditional | O.R. Solutions, Inc. | 11/13/2002SE |
| K023282 | ORS-3000LDLHC · Traditional | O.R. Solutions, Inc. | 11/13/2002SE |
| K021288 | ORS-1000LDLHC · Traditional | O.R. Solutions, Inc. | 06/27/2002SE |
More from O.R. Solutions, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K182164 | Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU…NHV · Special | 03/29/2019SE |
| K173164 | Ecolab POU Water FilterNHV · Traditional | 06/29/2018SE |
| K152522 | ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming DrapesLHC · Special | 01/15/2016SE |
| K150190 | IntraTemp Solution WarmerLHC · Special | 02/26/2015SE |
| K142173 | Non-Sterile ORS-400N Scope Pillow Warmer DrapeLHC · Traditional | 12/30/2014SE |
| K883593 | #400 Brook Airway & #900 Professional Brook AirwayCAE · Traditional | 09/30/1988SE |
Questions and answers
When was Non-Sterile Ors Warning Drapes/Slush+Warmer Disc-Drape/Slush+Warmer Palte-Drape /Fluid Warmer Drape,Skirted cleared by the FDA?
Non-Sterile Ors Warning Drapes/Slush+Warmer Disc-Drape/Slush+Warmer Palte-Drape /Fluid Warmer Drape,Skirted (K142080) received a 510(k) decision of Substantially Equivalent on August 28, 2014, 28 days after the submission was received.
What is the product code of K142080?
The FDA product code is LHC – Warmer, Irrigation Solution, a Class I (low risk) device regulated under 21 CFR 890.5950.