K040632 is an FDA 510(k) clearance for the SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000. This device is classified as a System, Thermal Regulating (Class II - Special Controls, product code DWJ).
Submitted by Smiths Medical Asd, Inc. (Rockland, US). The FDA issued a Cleared decision on April 27, 2004, 48 days after receiving the submission on March 10, 2004.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5900. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K040632 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 2004 |
| Decision Date | April 27, 2004 |
| Days to Decision | 48 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWJ — System, Thermal Regulating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5900 |
| Definition | If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |