The following data is part of a premarket notification filed by Contec Medical System Co., Ltd. with the FDA for Ambulatory Bllod Pressure Monitor, Electronic Sphygmomanometer,.
| Device ID | K110156 |
| 510k Number | K110156 |
| Device Name: | AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER, |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | CONTEC MEDICAL SYSTEM CO., LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Diana Hong CONTEC MEDICAL SYSTEM CO., LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-19 |
| Decision Date | 2011-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945040100348 | K110156 | 000 |