The following data is part of a premarket notification filed by Contec Medical System Co., Ltd. with the FDA for Contec Electrocardiograph.
Device ID | K131900 |
510k Number | K131900 |
Device Name: | CONTEC ELECTROCARDIOGRAPH |
Classification | Electrocardiograph |
Applicant | CONTEC MEDICAL SYSTEM CO., LTD. P.O. BOX 120-119 Shanghai, CN 200120 |
Contact | Diana Hong |
Correspondent | Diana Hong CONTEC MEDICAL SYSTEM 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 | 2013-06-25 |
Decision Date | 2014-03-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06945040100492 | K131900 | 000 |
06945040100089 | K131900 | 000 |
06945040100072 | K131900 | 000 |
06945040105756 | K131900 | 000 |