The following data is part of a premarket notification filed by Health & Life Co., Ltd. with the FDA for Modification To:hl168d Blood Pressure Monitor.
| Device ID | K012310 |
| 510k Number | K012310 |
| Device Name: | MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | HEALTH & LIFE CO., LTD. 6F,NO.407, CHUNG SHAN RD. SEC.02, CHUNG HO CITY Taipei Hsien, TW 235 |
| Contact | Susan Chen |
| Correspondent | Susan Chen HEALTH & LIFE CO., LTD. 6F,NO.407, CHUNG SHAN RD. SEC.02, 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 | 2001-07-23 |
| Decision Date | 2001-08-22 |