The following data is part of a premarket notification filed by Ageless Health Industrial Co., Ltd with the FDA for Age Automatic Upper Arm Blood Pressure Monitor With Models Ba-815, Ba-816, Ba-818 And Ba-819.
| Device ID | K172895 |
| 510k Number | K172895 |
| Device Name: | AGE Automatic Upper Arm Blood Pressure Monitor With Models BA-815, BA-816, BA-818 And BA-819 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| 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 | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-22 |
| Decision Date | 2018-06-18 |
| Summary: | summary |