The following data is part of a premarket notification filed by Shenzhen Creative Industry Co., Ltd with the FDA for Model Pc-860 Fetal Doppler.
| Device ID | K082055 |
| 510k Number | K082055 |
| Device Name: | MODEL PC-860 FETAL DOPPLER |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | SHENZHEN CREATIVE INDUSTRY CO., LTD 2/F, BLOCK 3, NANYOU TIAN'AN INDUSTRY TOWN Shenzhen, Guangdong, CN 518054 |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-07-21 |
| Decision Date | 2009-02-06 |
| Summary: | summary |