The following data is part of a premarket notification filed by Sims Level 1, Inc. with the FDA for Snuggle Warm 4000 Convective Warming System.
| Device ID | K011907 |
| 510k Number | K011907 |
| Device Name: | SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM |
| Classification | System, Thermal Regulating |
| Applicant | SIMS LEVEL 1, INC. 160 WEYMOUTH ST. Rockland, MA 02370 |
| Contact | Gabriel J Muraca, Jr. |
| Correspondent | Gabriel J Muraca, Jr. SIMS LEVEL 1, INC. 160 WEYMOUTH ST. Rockland, MA 02370 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-18 |
| Decision Date | 2001-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50695085850005 | K011907 | 000 |
| 10695085000013 | K011907 | 000 |
| 10695085000020 | K011907 | 000 |
| 10695085000037 | K011907 | 000 |
| 10695085000044 | K011907 | 000 |
| 10695085001775 | K011907 | 000 |
| 10695085480020 | K011907 | 000 |
| 50695085000653 | K011907 | 000 |
| 50695085001810 | K011907 | 000 |
| 50695085002657 | K011907 | 000 |
| 50695085003593 | K011907 | 000 |
| 50695085003616 | K011907 | 000 |
| 50695085003630 | K011907 | 000 |
| 15019517042474 | K011907 | 000 |