The following data is part of a premarket notification filed by Mediana Co., Ltd. with the FDA for Dt-100.
| Device ID | K160358 |
| 510k Number | K160358 |
| Device Name: | DT-100 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Mediana Co., Ltd. 132, Donghwagongdan-ro, Munmak-eup Wonju-si, KR 220-801 |
| Contact | Min-hye Kim |
| Correspondent | Charlie Mack International Regulatory Consultants 2550 Duportail Street M275 Richland, WA 99352 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-09 |
| Decision Date | 2017-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18800003445537 | K160358 | 000 |