The following data is part of a premarket notification filed by Oriental System Technology, Inc. with the FDA for Tempteller Infared Ear Thermometers, Model Ct-31/31dx/32/32dx.
| Device ID | K030299 |
| 510k Number | K030299 |
| Device Name: | TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-29 |
| Decision Date | 2003-02-25 |
| Summary: | summary |