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 |