The following data is part of a premarket notification filed by Deroyal Critical Care, Div. Deroyal Technologies with the FDA for Deroyal Technologices, Inc. Liquid Crystal Skin Temperature Strip.
| Device ID | K946046 |
| 510k Number | K946046 |
| Device Name: | DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE STRIP |
| Classification | Thermometer, Clinical Color Change |
| Applicant | DEROYAL CRITICAL CARE, DIV. DEROYAL TECHNOLOGIES 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Debra F Manning |
| Correspondent | Debra F Manning DEROYAL CRITICAL CARE, DIV. DEROYAL TECHNOLOGIES 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | FQZ |
| CFR Regulation Number | 880.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-12 |
| Decision Date | 1995-07-19 |