The following data is part of a premarket notification filed by Ageless Health Industrial Co., Ltd with the FDA for Ageless Health Medical Digital Thermometer.
| Device ID | K172508 |
| 510k Number | K172508 |
| Device Name: | Ageless Health Medical Digital Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Ageless Health Industrial Co., Ltd 3/F, A1 Bldg, Dongshen Sima Industrial Area, No.33 Shenbei Road, Sima Village, Dongguan, CN 523000 |
| 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 | 2017-08-21 |
| Decision Date | 2018-08-08 |
| Summary: | summary |