NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED
FDA 510(k) clearance K142080 · decided 2014-08-28
Clearance details
- K-number
- K142080
- Device name
- NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED
- Applicant
- Ecolab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-07-31
- Decision date
- 2014-08-28
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- LHC
- Device class
- 1
- Regulation number
- 890.5950
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Saint Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Getinge Series Warming Cabinet (K153713) | Getinge Sourcing, LLC | 2016-06-07 |
| ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes (K152522) | Ecolab, Inc. | 2016-01-15 |
| IntraTemp Solution Warmer (K150190) | Ecolab, Inc. | 2015-02-26 |
| NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE (K142173) | Ecolab, Inc. | 2014-12-30 |
| INTRATEMP SOLUTION WARMER (K083417) | C Change Surgical, LLC | 2009-01-13 |
| SWC/DWC WARMING CABINETS (K080609) | Mac Medical | 2008-06-13 |
| C CHANGE SOLUTION WARMER (K051819) | C Change Surgical, LLC | 2005-08-15 |
| ORS-3000LD (K023282) | O.R. Solutions, Inc. | 2002-11-13 |
| 1075LD HUSH-SLUSH (K023283) | O.R. Solutions, Inc. | 2002-11-13 |
| ORS-1000LD (K021288) | O.R. Solutions, Inc. | 2002-06-27 |
| WARMER 2000LD (K021289) | O.R. Solutions, Inc. | 2002-06-26 |
| SSW-STERILE SOLUTION WARMER (K002859) | Kmi Kolster Methods, Inc. | 2000-11-16 |