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 Hl868bf.
| Device ID | K092161 |
| 510k Number | K092161 |
| Device Name: | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF |
| 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 | Tzu-wei Li CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL BLDG. 16, 321 KUANG FU RD,SEC2 Hsinchu,, TW |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-07-16 |
| Decision Date | 2009-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14719872489020 | K092161 | 000 |
| 14719872489013 | K092161 | 000 |
| 04719872483151 | K092161 | 000 |
| 14719872483103 | K092161 | 000 |