HotDog Temperature Management Controller
FDA 510(k) clearance K201779 · decided 2020-09-11
Clearance details
- K-number
- K201779
- Device name
- HotDog Temperature Management Controller
- Applicant
- Augustine Temperature Management
- Decision
- Substantially Equivalent
- Date received
- 2020-06-30
- Decision date
- 2020-09-11
- Days to decision
- 73 days
- Clearance type
- Special
- Product code
- DWJ
- Device class
- 2
- Regulation number
- 870.5900
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single recall (Z-0839-2025) | Augustine Temperature Management, LLC | 2025-01-10 |
| Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single recall (Z-0700-2025) | Augustine Temperature Management, LLC | 2024-12-18 |
| Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multip recall (Z-0701-2025) | Augustine Temperature Management, LLC | 2024-12-18 |
| Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with W recall (Z-0702-2025) | Augustine Temperature Management, LLC | 2024-12-18 |