The following data is part of a premarket notification filed by Contec Medical Systems Co., Ltd. with the FDA for Electronic Sphygmomanometer.
| Device ID | K110775 |
| 510k Number | K110775 |
| Device Name: | ELECTRONIC SPHYGMOMANOMETER |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | CONTEC MEDICAL SYSTEMS CO., LTD. P.O. BOX 237-423 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Diana Hong CONTEC MEDICAL SYSTEMS CO., LTD. P.O. BOX 237-423 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 | 2011-03-21 |
| Decision Date | 2011-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945040100331 | K110775 | 000 |
| 06945040106258 | K110775 | 000 |