The following data is part of a premarket notification filed by Steris Corporation with the FDA for Steris Patient Warming System.
| Device ID | K200446 |
| 510k Number | K200446 |
| Device Name: | STERIS Patient Warming System |
| Classification | System, Thermal Regulating |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | Gregory Land |
| Correspondent | Gregory Land STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-24 |
| Decision Date | 2020-06-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995194246 | K200446 | 000 |
| 00724995194239 | K200446 | 000 |
| 00724995194222 | K200446 | 000 |
| 00724995194215 | K200446 | 000 |
| 00724995194208 | K200446 | 000 |