The following data is part of a premarket notification filed by Health & Life Co., Ltd. with the FDA for Hl168r.
| Device ID | K031695 |
| 510k Number | K031695 |
| Device Name: | HL168R |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | HEALTH & LIFE CO., LTD. 9F, NO.186, JIAN YI ROAD Chung Ho City, Taipei, Hsien, TW 235 |
| Contact | Susan Chen |
| Correspondent | Susan Chen HEALTH & LIFE CO., LTD. 9F, NO.186, JIAN YI ROAD Chung Ho City, Taipei, Hsien, TW 235 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-02 |
| Decision Date | 2003-07-01 |