The following data is part of a premarket notification filed by Health & Life Co., Ltd. with the FDA for Full Automatic (nibp) Blood Pressure Monitor, Model Hl158bt.
| Device ID | K093824 |
| 510k Number | K093824 |
| Device Name: | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL158BT |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | HEALTH & LIFE CO., LTD. 9F, NO.186, JIAN YI ROAD Chung Ho City, Taipei, TW 235 |
| Contact | Sarah Su |
| Correspondent | Sarah Su HEALTH & LIFE CO., LTD. 9F, NO.186, JIAN YI ROAD Chung Ho City, Taipei, 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 | 2009-12-14 |
| Decision Date | 2010-02-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14719872480232 | K093824 | 000 |
| 14719872480225 | K093824 | 000 |
| 14719872480218 | K093824 | 000 |
| 14719872480102 | K093824 | 000 |
| 14719872480072 | K093824 | 000 |