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 |