K090009 is an FDA 510(k) clearance for the THD SLIDE ONE. This device is classified as a Monitor, Ultrasonic, Nonfetal (Class II - Special Controls, product code JAF).
Submitted by Thd Spa (North Reading, US). The FDA issued a Cleared decision on January 28, 2009, 26 days after receiving the submission on January 2, 2009.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1540.
| 510(k) Number | K090009 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 2009 |
| Decision Date | January 28, 2009 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAF - Monitor, Ultrasonic, Nonfetal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1540 |