Fever Garde
510(k) K191978
Fever Garde is a Class II device made by HuBDIC Co., Ltd., cleared under FDA 510(k) K191978 on 18 Dec 2020, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK191978 | Date18 Dec 2020 | StatusActive |
Official records
- FDA 510(k) database K191978
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FLL
- Device class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K191978
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Fever Garde HMT-100 | HMT-100 | 08800132200413 | — | On the market |
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Other devices filed under FDA product code FLL (Continuous Measurement Thermometer).
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- TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370 by Truly Instrument Limited
- FEVER MONITORING KIT by Polymedica Healthcare, Inc.