The following data is part of a premarket notification filed by Drtech Corp. with the FDA for Flaatz 500.
| Device ID | K091747 |
| 510k Number | K091747 |
| Device Name: | FLAATZ 500 |
| Classification | System, X-ray, Stationary |
| Applicant | DRTECH CORP. 333-1, SANGDEAWON 1-DONG JUNGWON-GU Seongnam-shi, Gyeonggi-do, KR 462-807 |
| Contact | Beom-jin Moon |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-06-16 |
| Decision Date | 2009-07-01 |
| Summary: | summary |