The following data is part of a premarket notification filed by Changshan Estar Electronics Co., Ltd. with the FDA for Ect Digital Thermometer.
| Device ID | K101043 |
| 510k Number | K101043 |
| Device Name: | ECT DIGITAL THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | CHANGSHAN ESTAR ELECTRONICS CO., LTD. # 462, SEC 2, CHONGDE ROAD BEITUN DISTRICT Taichung, TW 406 |
| Contact | Jacob Chang |
| Correspondent | Jacob Chang CHANGSHAN ESTAR ELECTRONICS CO., LTD. # 462, SEC 2, CHONGDE ROAD BEITUN DISTRICT Taichung, TW 406 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-14 |
| Decision Date | 2010-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00024291281177 | K101043 | 000 |