The following data is part of a premarket notification filed by International Regulatory Consultants, Llc (irc) with the FDA for Digital Thermometer; Digital Thermometer.
| Device ID | K102718 |
| 510k Number | K102718 |
| Device Name: | DIGITAL THERMOMETER; DIGITAL THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | INTERNATIONAL REGULATORY CONSULTANTS, LLC (IRC) 16F-2(16A), SEC. 2 CHONG DE RD Taichung, CN 406 |
| Contact | Jacob Chang |
| Correspondent | Jacob Chang INTERNATIONAL REGULATORY CONSULTANTS, LLC (IRC) 16F-2(16A), SEC. 2 CHONG DE RD Taichung, CN 406 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-21 |
| Decision Date | 2010-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00639277388148 | K102718 | 000 |
| 00049696299923 | K102718 | 000 |
| 00860007291111 | K102718 | 000 |
| 00049696739795 | K102718 | 000 |
| 00049696739351 | K102718 | 000 |
| 00049696738132 | K102718 | 000 |
| 00049696731379 | K102718 | 000 |
| 00032251549762 | K102718 | 000 |
| 00032251549779 | K102718 | 000 |
| 00032251549786 | K102718 | 000 |
| 00860007291128 | K102718 | 000 |