The following data is part of a premarket notification filed by Alicn Medical Shenzhen,inc with the FDA for Infrared Thermometer, Model: Aet-r1b1, Aet-r161, Aet-r171, Aet-r1d1, Aet-r1d2, Aet-r1f1, Aet-r701, Aet-r711.
| Device ID | K210565 |
| 510k Number | K210565 |
| Device Name: | Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Alicn Medical Shenzhen,Inc Room 410, Building A, 3rd Sub-park, Leibo Zhongcheng Life Science Park, Kengzi Shenzhen, CN 518118 |
| Contact | Fang Meisong |
| Correspondent | Fang Meisong Alicn Medical Shenzhen,Inc Room 410, Building A, 3rd Sub-park, Leibo Zhongcheng Life Science Park, Kengzi Shenzhen, CN 518118 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-25 |
| Decision Date | 2022-05-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810477028083 | K210565 | 000 |
| 00810477028052 | K210565 | 000 |
| 00810477023101 | K210565 | 000 |
| 00810477022876 | K210565 | 000 |
| 00810477022821 | K210565 | 000 |
| 00810477022807 | K210565 | 000 |
| 00810477021558 | K210565 | 000 |
| 06953775661249 | K210565 | 000 |
| 06953775661607 | K210565 | 000 |