The following data is part of a premarket notification filed by Oriental System Technology, Inc. with the FDA for Temp Teller-infrared Tympanic Thermometer, Models Tt-200, Tt-201.
| Device ID | K984497 |
| 510k Number | K984497 |
| Device Name: | TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201 |
| 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 | 1998-12-17 |
| Decision Date | 1999-05-26 |
| Summary: | summary |