The following data is part of a premarket notification filed by Health & Life Co., Ltd. with the FDA for Hl888sf.
| Device ID | K060835 |
| 510k Number | K060835 |
| Device Name: | HL888SF |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | HEALTH & LIFE CO., LTD. 9F, NO.186, JIAN YI ROAD Chung Ho City, Taipei, TW 23553 |
| Contact | Alex Kou |
| Correspondent | Alex Kou HEALTH & LIFE CO., LTD. 9F, NO.186, JIAN YI ROAD Chung Ho City, Taipei, TW 23553 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-27 |
| Decision Date | 2006-04-21 |
| Summary: | summary |