K153475 is an FDA 510(k) clearance for the SD5 & SD6 Ultrasonic Tabletop Doppler. This device is classified as a Monitor, Ultrasonic, Fetal (Class II - Special Controls, product code KNG).
Submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on January 29, 2016, 58 days after receiving the submission on December 2, 2015.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 884.2660.
| 510(k) Number | K153475 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2015 |
| Decision Date | January 29, 2016 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KNG — Monitor, Ultrasonic, Fetal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2660 |