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 Hl168kf).
| Device ID | K113239 |
| 510k Number | K113239 |
| Device Name: | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF) |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | HEALTH & LIFE CO., LTD. 9F, NO.186, JIAN YI ROAD Zhonghe District, New Taipei, TW 23553 |
| Contact | Sarah Su |
| Correspondent | Sarah Su HEALTH & LIFE CO., LTD. 9F, NO.186, JIAN YI ROAD Zhonghe District, New Taipei, TW 23553 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-02 |
| Decision Date | 2012-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850842006063 | K113239 | 000 |
| 00850842006056 | K113239 | 000 |