The following data is part of a premarket notification filed by Hubdic Co., Ltd with the FDA for Thermofinder; Thermocare.
| Device ID | K130361 |
| 510k Number | K130361 |
| Device Name: | THERMOFINDER; THERMOCARE |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | HUBDIC CO., LTD 504 BLUEGRASS DRIVE Canonsburg, PA 15317 |
| Contact | Matt Hansen |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-02-13 |
| Decision Date | 2013-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800132200246 | K130361 | 000 |
| 08800132200239 | K130361 | 000 |
| 08800132200178 | K130361 | 000 |
| 08800132200161 | K130361 | 000 |