K082055 is an FDA 510(k) clearance for the MODEL PC-860 FETAL DOPPLER. This device is classified as a Monitor, Ultrasonic, Fetal (Class II - Special Controls, product code KNG).
Submitted by Shenzhen Creative Industry Co., Ltd. (Chenzhen City, CN). The FDA issued a Cleared decision on February 6, 2009, 200 days after receiving the submission on July 21, 2008.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2660.
| 510(k) Number | K082055 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 2008 |
| Decision Date | February 06, 2009 |
| Days to Decision | 200 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | KNG - Monitor, Ultrasonic, Fetal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2660 |