The following data is part of a premarket notification filed by Cotronic Manufacturing with the FDA for Cotronic Digital Thermometer.
| Device ID | K103407 |
| 510k Number | K103407 |
| Device Name: | COTRONIC DIGITAL THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | COTRONIC MANUFACTURING 23 JOSIAH AVE San Francisco, CA 94112 |
| Contact | Yan Dur Lin |
| Correspondent | Yan Dur Lin COTRONIC MANUFACTURING 23 JOSIAH AVE San Francisco, CA 94112 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-19 |
| Decision Date | 2011-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817746020243 | K103407 | 000 |
| 00878931003205 | K103407 | 000 |