The following data is part of a premarket notification filed by Hubdic Co., Ltd. with the FDA for Fever Garde.
| Device ID | K191978 |
| 510k Number | K191978 |
| Device Name: | Fever Garde |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | HuBDIC Co., Ltd. 301, 53 Jeonpa-ro, Mana-gu, Anyang-si, Gyongg-do Anyang-si, KR 14084 |
| Contact | Shin Jae-ho |
| Correspondent | Peter Chung Plus Global 300 Atwood Pittsburgh, PA 15213 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-24 |
| Decision Date | 2020-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800132200413 | K191978 | 000 |