The following data is part of a premarket notification filed by Blazie Engineering, Inc. with the FDA for Clinical Voice Thermometer.
| Device ID | K935466 |
| 510k Number | K935466 |
| Device Name: | CLINICAL VOICE THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | BLAZIE ENGINEERING, INC. 105 E. JARRETTSVILLE RD. Forest Hill, MD 21050 |
| Contact | Deane Blazie |
| Correspondent | Deane Blazie BLAZIE ENGINEERING, INC. 105 E. JARRETTSVILLE RD. Forest Hill, MD 21050 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-12 |
| Decision Date | 1995-04-13 |