SIMPEX INC. ORAL AND RECTAL THERMOMETERS
Device Facts
| Record ID | K913793 |
|---|---|
| Device Name | SIMPEX INC. ORAL AND RECTAL THERMOMETERS |
| Applicant | Simpex, Inc. |
| Product Code | FLK · General Hospital |
| Decision Date | Dec 30, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.2920 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A clinical mercury thermometer is a device used to measure oral, rectal, or axillary (armpit) body temperature using the thermal expansion of mercury.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
