The following data is part of a premarket notification filed by China Shenyang Med-land Imp/exp Corp., Ltd. with the FDA for (multiple) Digital Thermometer.
| Device ID | K120004 |
| 510k Number | K120004 |
| Device Name: | (MULTIPLE) DIGITAL THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | CHINA SHENYANG MED-LAND IMP/EXP CORP., LTD. 19 SEDGEMEADOW RD Wayland, MA 01778 |
| Contact | Ann D Mcgonigle |
| Correspondent | Ann D Mcgonigle CHINA SHENYANG MED-LAND IMP/EXP CORP., LTD. 19 SEDGEMEADOW RD Wayland, MA 01778 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-03 |
| Decision Date | 2012-08-23 |
| Summary: | summary |