The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Level 1 Snuggle Warm Pediatric And Large Pediatric Underbody Blanket.
| Device ID | K061513 |
| 510k Number | K061513 |
| Device Name: | LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET |
| Classification | System, Thermal Regulating |
| Applicant | SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Contact | Timothy J Talcott |
| Correspondent | Timothy J Talcott SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-01 |
| Decision Date | 2006-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10695085001782 | K061513 | 000 |
| 10695085000723 | K061513 | 000 |