The following data is part of a premarket notification filed by Clinical Technology Corp. with the FDA for Urinary Bladder Temp. Sensor #81-003.
| Device ID | K823077 |
| 510k Number | K823077 |
| Device Name: | URINARY BLADDER TEMP. SENSOR #81-003 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | CLINICAL TECHNOLOGY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-19 |
| Decision Date | 1983-03-09 |