The following data is part of a premarket notification filed by Shenzhen Biocare Electronics Co., Ltd with the FDA for Doppler Fetal Heart Rate Detector, Model Fm-200.
| Device ID | K100626 |
| 510k Number | K100626 |
| Device Name: | DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200 |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | SHENZHEN BIOCARE ELECTRONICS CO., LTD SUITE 5D, NO 19, LANE 999 ZHONGSHAN NO. 2 ROAD(S) Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong SHENZHEN BIOCARE ELECTRONICS CO., LTD SUITE 5D, NO 19, LANE 999 ZHONGSHAN NO. 2 ROAD(S) Shanghai, CN 200030 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-05 |
| Decision Date | 2010-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06937683443128 | K100626 | 000 |