The following data is part of a premarket notification filed by Micro Idea Instrument Co., Ltd. with the FDA for Digital Thermometer.
| Device ID | K851146 |
| 510k Number | K851146 |
| Device Name: | DIGITAL THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MICRO IDEA INSTRUMENT CO., LTD. R. 501, NO 147, SEC. 2 CHIEN KUO North Road Taipei, Taiwan, TW |
| Contact | Lin |
| Correspondent | Lin MICRO IDEA INSTRUMENT CO., LTD. R. 501, NO 147, SEC. 2 CHIEN KUO North Road Taipei, Taiwan, TW |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-21 |
| Decision Date | 1985-05-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10328785000457 | K851146 | 000 |
| 00328785000443 | K851146 | 000 |
| 00328785000269 | K851146 | 000 |
| B268Y7078A71 | K851146 | 000 |