The following data is part of a premarket notification filed by Oriental System Technology, Inc. with the FDA for Temp Teller - Digital Thermometer, Models Dt-101, Dt-102, Dt-103, Dt-201, Dt-202, Dt-203.
| Device ID | K992601 |
| 510k Number | K992601 |
| Device Name: | TEMP TELLER - DIGITAL THERMOMETER, MODELS DT-101, DT-102, DT-103, DT-201, DT-202, DT-203 |
| 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 | 1999-08-03 |
| Decision Date | 1999-10-27 |
| Summary: | summary |