The following data is part of a premarket notification filed by Oriental System Technology, Inc. with the FDA for Tempteller Infrared Ear Thermometer, Model Ct-30/ Ct-30dx.
| Device ID | K010235 |
| 510k Number | K010235 |
| Device Name: | TEMPTELLER INFRARED EAR THERMOMETER, MODEL CT-30/ CT-30DX |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | ORIENTAL SYSTEM TECHNOLOGY, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk ORIENTAL SYSTEM TECHNOLOGY, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-25 |
| Decision Date | 2001-07-09 |