K092997 is an FDA 510(k) clearance for the ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6. This device is classified as a Monitor, Ultrasonic, Fetal (Class II - Special Controls, product code KNG).
Submitted by Edan Instruments, Inc. (Yonkers, US). The FDA issued a Cleared decision on November 10, 2009, 43 days after receiving the submission on September 28, 2009.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 884.2660.
| 510(k) Number | K092997 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2009 |
| Decision Date | November 10, 2009 |
| Days to Decision | 43 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 |