The following data is part of a premarket notification filed by Contec Medical Systems Co.,ltd with the FDA for Portable Ecg Monitor.
| Device ID | K170954 |
| 510k Number | K170954 |
| Device Name: | Portable ECG Monitor |
| Classification | Electrocardiograph |
| Applicant | CONTEC Medical Systems Co.,Ltd No.112 Qinhuang West Street, Economic& Technical Development Qinhuangdao, CN 066004 |
| Contact | Xueyong Li |
| Correspondent | Diana Hong Mid-Link Consulting Co.,Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-31 |
| Decision Date | 2017-05-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945040104421 | K170954 | 000 |