The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Exac-temp & Clini-temp Tympanic & Myocardial Probe.
| Device ID | K925792 |
| 510k Number | K925792 |
| Device Name: | EXAC-TEMP & CLINI-TEMP TYMPANIC & MYOCARDIAL PROBE |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Debra F Manning |
| Correspondent | Debra F Manning DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-16 |
| Decision Date | 1994-04-08 |