The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Level 1 Convective Warmer.
| Device ID | K181699 |
| 510k Number | K181699 |
| Device Name: | Level 1 Convective Warmer |
| Classification | System, Thermal Regulating |
| Applicant | Smiths Medical ASD, Inc. 6000 Nathan Lane Minneapolis, MN 55442 |
| Contact | Donna M. Semlak |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-06-27 |
| Decision Date | 2018-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15019517121551 | K181699 | 000 |
| 15019517100457 | K181699 | 000 |
| 15019517100297 | K181699 | 000 |
| 15019517100280 | K181699 | 000 |
| 15019517100273 | K181699 | 000 |
| 15019517100303 | K181699 | 000 |