The following data is part of a premarket notification filed by Wiltec Industries Ltd. with the FDA for Electronic Thermometer.
| Device ID | K961879 |
| 510k Number | K961879 |
| Device Name: | ELECTRONIC THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | WILTEC INDUSTRIES LTD. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden WILTEC INDUSTRIES LTD. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-15 |
| Decision Date | 1996-06-10 |