The following data is part of a premarket notification filed by Thermomedics Inc. with the FDA for Caregiver Professional Clinical Thermometer, Pro-tf Series.
| Device ID | K131771 |
| 510k Number | K131771 |
| Device Name: | CAREGIVER PROFESSIONAL CLINICAL THERMOMETER, PRO-TF SERIES |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | THERMOMEDICS INC. 6F, NO. 127, WUGONG 2ND RD., WUGU DISTRICT New Taipei City, TW 24888 |
| Contact | Paul Liu |
| Correspondent | Paul Liu THERMOMEDICS INC. 6F, 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-17 |
| Decision Date | 2013-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04710469873409 | K131771 | 000 |
| 00852119002051 | K131771 | 000 |