The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Ion Health Usb Insta-scan Thermometer.
| Device ID | K111974 |
| 510k Number | K111974 |
| Device Name: | ION HEALTH USB INSTA-SCAN THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | TaiDoc Technology Corporation 3F,5F, NO.127 WUGONG 2ND RD, WUGU DISTRICT New Taipei City, TW 24888 |
| Contact | Teling Hsu |
| Correspondent | Teling Hsu TaiDoc Technology Corporation 3F,5F, NO.127 WUGONG 2ND RD, WUGU DISTRICT New Taipei City, TW 24888 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-12 |
| Decision Date | 2011-08-15 |
| Summary: | summary |