The following data is part of a premarket notification filed by Augustine Biomedical & Design, Llc with the FDA for Hotdog Patient Warming System.
| Device ID | K112488 |
| 510k Number | K112488 |
| Device Name: | HOTDOG PATIENT WARMING SYSTEM |
| Classification | System, Thermal Regulating |
| Applicant | AUGUSTINE BIOMEDICAL & DESIGN, LLC 6581 CITY WEST PARKWAY Eden Prairie, MN 55344 |
| Contact | Wendy Nelson |
| Correspondent | Wendy Nelson AUGUSTINE BIOMEDICAL & DESIGN, LLC 6581 CITY WEST PARKWAY Eden Prairie, MN 55344 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-29 |
| Decision Date | 2011-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855913001923 | K112488 | 000 |
| 00855913001916 | K112488 | 000 |
| 00855913001909 | K112488 | 000 |
| 00855913001091 | K112488 | 000 |
| 00850011479629 | K112488 | 000 |
| 00850011479612 | K112488 | 000 |
| 00850011479605 | K112488 | 000 |
| 00850011479599 | K112488 | 000 |
| 00855913001992 | K112488 | 000 |