The following data is part of a premarket notification filed by Contec Medical System Co., Ltd. with the FDA for Contec Pocket Fetal Doppler.
| Device ID | K082480 |
| 510k Number | K082480 |
| Device Name: | CONTEC POCKET FETAL DOPPLER |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | CONTEC MEDICAL SYSTEM CO., LTD. SUITE 8D , ZHONGXIN ZHONGSHAN MANSION, NO. 19, LANE 999, Zhong Shan, Shanghai, CN 20030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong CONTEC MEDICAL SYSTEM CO., LTD. SUITE 8D , ZHONGXIN ZHONGSHAN MANSION, NO. 19, LANE 999, Zhong Shan, Shanghai, CN 20030 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-28 |
| Decision Date | 2009-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628055787051 | K082480 | 000 |
| 00860005571932 | K082480 | 000 |
| 00860005571901 | K082480 | 000 |
| 06945040100140 | K082480 | 000 |
| 06945040100157 | K082480 | 000 |
| 06945040100287 | K082480 | 000 |
| 06945040104612 | K082480 | 000 |
| 00851908007048 | K082480 | 000 |
| 00851908007109 | K082480 | 000 |
| 00851908007116 | K082480 | 000 |
| 00851908007130 | K082480 | 000 |
| 00851908007161 | K082480 | 000 |
| 00628055787013 | K082480 | 000 |
| 00897429002513 | K082480 | 000 |