The following data is part of a premarket notification filed by Andon Health Co., Ltd. with the FDA for Ihealth Clinical Digital Thermometer.
| Device ID | K202791 |
| 510k Number | K202791 |
| Device Name: | IHealth Clinical Digital Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Andon Health Co., Ltd. No. 3 Jin Ping Street, Ya An Road, Nankai District Tianjin, CN 300190 |
| Contact | Liu Yi |
| Correspondent | Liu Yi Andon Health Co., Ltd. No. 3 Jin Ping Street, Ya An Road, Nankai District Tianjin, CN 300190 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-22 |
| Decision Date | 2021-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10856362005811 | K202791 | 000 |