The following data is part of a premarket notification filed by Andon Health Co., Ltd. with the FDA for Ihealth Infrared Ear Thermometer Pt5.
| Device ID | K212598 |
| 510k Number | K212598 |
| Device Name: | IHealth Infrared Ear Thermometer PT5 |
| 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 | 2021-08-16 |
| Decision Date | 2022-01-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10856362005996 | K212598 | 000 |