The following data is part of a premarket notification filed by Encompass Group, Llc with the FDA for Nova Patient Warming System.
| Device ID | K203085 |
| 510k Number | K203085 |
| Device Name: | NOVA Patient Warming System |
| Classification | System, Thermal Regulating |
| Applicant | Encompass Group, LLC 615 Macon St Mcdonough, GA 30253 |
| Contact | Eric Howard |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-10-13 |
| Decision Date | 2020-11-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00612899006492 | K203085 | 000 |
| 50612899006480 | K203085 | 000 |
| 00612899006478 | K203085 | 000 |
| 00612899006430 | K203085 | 000 |