The following data is part of a premarket notification filed by Health & Life Co., Ltd. with the FDA for Fully Automatic (nibp) Blood Pressure Monitor, Model Hl868rt.
| Device ID | K093831 |
| 510k Number | K093831 |
| Device Name: | FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT |
| 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 | 2010-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14719872489075 | K093831 | 000 |
| 14719872489051 | K093831 | 000 |
| 14719872483257 | K093831 | 000 |
| 14719872483240 | K093831 | 000 |
| 04719872483137 | K093831 | 000 |
| 04719872483120 | K093831 | 000 |
| 04719872483113 | K093831 | 000 |