The following data is part of a premarket notification filed by Dongguan Ageless Health Industrial Co., Ltd with the FDA for Age Automatic Wrist Blood Pressure Monitor.
| Device ID | K151281 |
| 510k Number | K151281 |
| Device Name: | AGE Automatic Wrist Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | DONGGUAN AGELESS HEALTH INDUSTRIAL CO., LTD 3/F, A1 BLDG, DONGSHEN SIMA INDUSTRIAL AREA, NO.33 SHENBEI ROAD Dongguan, CN 523560 |
| Contact | Victor Wan |
| Correspondent | Cecilia Ceng GUANGZHOU GLOMED BIOLOGICAL TECHNOLOGY CO.,LTD SUITE 306, KECHENG MANSION, NO.121 SCIENCE ROAD, GUAHGZHOU 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 | 2015-05-14 |
| Decision Date | 2015-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06958682800149 | K151281 | 000 |
| 06958682800125 | K151281 | 000 |
| 06958682800071 | K151281 | 000 |
| 06958682800057 | K151281 | 000 |