The following data is part of a premarket notification filed by Dongguan E-test Technology Co., Ltd with the FDA for Digital Thermometer-(model Bt-301, Bt-302, Bt-303, Bt-305, Bt-306, Bt-308, Bt-311, Bt-318).
| Device ID | K193621 |
| 510k Number | K193621 |
| Device Name: | Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Dongguan E-Test Technology Co., Ltd Room 201, 301. Building 1, Changping Section No.1, Dongshen Road Dongguan, CN 523588 |
| Contact | Victor Wan |
| Correspondent | Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park Guangzhou, CN 510000 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-26 |
| Decision Date | 2020-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973826010529 | K193621 | 000 |
| 06973826010512 | K193621 | 000 |
| 06973826010505 | K193621 | 000 |
| 06973826010499 | K193621 | 000 |
| 06973826010482 | K193621 | 000 |
| 06973826010475 | K193621 | 000 |
| 06973826010017 | K193621 | 000 |
| 06973826010000 | K193621 | 000 |