The following data is part of a premarket notification filed by Oriental System Technology, Inc. with the FDA for Tempteller - High Speed Digital Thermometers, Models Dt-302, Dt-312, Dt-412, Dt-502.
| Device ID | K042202 |
| 510k Number | K042202 |
| Device Name: | TEMPTELLER - HIGH SPEED DIGITAL THERMOMETERS, MODELS DT-302, DT-312, DT-412, DT-502 |
| 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 | 2004-08-13 |
| Decision Date | 2004-09-10 |
| Summary: | summary |