The following data is part of a premarket notification filed by Pintler Medical with the FDA for Pintler Patient Warming System.
| Device ID | K113705 |
| 510k Number | K113705 |
| Device Name: | PINTLER PATIENT WARMING SYSTEM |
| Classification | System, Thermal Regulating |
| Applicant | PINTLER MEDICAL 3220 S. HANFORD STREET Seattle, WA 98144 |
| Contact | Maribeth Macintyre-ellis |
| Correspondent | Paula Wilkerson INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-12-16 |
| Decision Date | 2012-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B389PPWS0011 | K113705 | 000 |