The following data is part of a premarket notification filed by Health & Life Co., Ltd. with the FDA for Hl148 & Hl168.
| Device ID | K990807 |
| 510k Number | K990807 |
| Device Name: | HL148 & HL168 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | HEALTH & LIFE CO., LTD. 4F-3, NO. 351, CHUNG SHAN RD. SEC.02, CHUNG HO CITY Taipei Hsien, TW |
| Contact | Susan Chen |
| Correspondent | Susan Chen HEALTH & LIFE CO., LTD. 4F-3, NO. 351, CHUNG SHAN RD. SEC.02, CHUNG HO CITY Taipei Hsien, TW |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-11 |
| Decision Date | 1999-12-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14719872480188 | K990807 | 000 |
| 14719872480164 | K990807 | 000 |