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.
| Device ID | K153552 |
| 510k Number | K153552 |
| Device Name: | AGE Automatic Upper Arm Blood Pressure Monitor |
| 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 Dongguan, CN 523560 |
| Contact | Victor Wan |
| Correspondent | Cecelia Ceng Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, CN 510663 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-11 |
| Decision Date | 2016-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888277720346 | K153552 | 000 |