The following data is part of a premarket notification filed by Andon Health Co.,ltd with the FDA for Ihealth Wireless Blood Pressure Monitor.
| Device ID | K162144 |
| 510k Number | K162144 |
| Device Name: | IHealth Wireless Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | ANDON HEALTH CO.,LTD NO 3 JIN PING STREET YA AN RD NANKAI DISTRICT Tianjin, CN 300190 |
| Contact | Liu Yi |
| Correspondent | Liu Yi ANDON HEALTH CO.,LTD NO 3 JIN PING STREET YA AN RD NANKAI DISTRICT Tianjin, CN 300190 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-01 |
| Decision Date | 2017-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10856362005057 | K162144 | 000 |