FLK · Thermometer, Clinical Mercury
General Hospital · 21 CFR 880.2920 · Class 2
Overview
| Product Code | FLK |
|---|---|
| Device Name | Thermometer, Clinical Mercury |
| Regulation | 21 CFR 880.2920 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
A clinical mercury thermometer is a device used to measure oral, rectal, or axillary (armpit) body temperature using the thermal expansion of mercury.
Classification Rationale
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.
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.
Recent Cleared Devices (20 of 33)
Showing 20 most recent of 33 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K960185 | AMSINO CLINICAL THERMOMETER | Amsia Intl., Inc. | Mar 28, 1996 | SESE |
| K960224 | GERATHERM MERCUIRY FREE CLINICAL THERMOMETER | Rg Ent., Inc. | Mar 25, 1996 | SESE |
| K953465 | KENTEMP | Kentron Health Care, Inc. | Dec 15, 1995 | SESE |
| K942483 | CLINICAL GLASS THERMOMETER | Makol Medical Instruments Corp. | Mar 28, 1995 | SESE |
| K941673 | MEDIAID UNIVERSAL THERMOMETER | Polymedica Industries, Inc. | Aug 25, 1994 | SESE |
| K940394 | AMG MED BRAND CLINICAL GLASS THERMOMETER | Technolab Industries (Canada) , Ltd. | May 4, 1994 | SESE |
| K940380 | AMG MED BRAND CLINICAL GLASS THERMOMETER | Amg Medical, Inc. | May 4, 1994 | SESE |
| K932991 | GUARDIAN AND ANDINO MODELS | Coltemp, Inc. | Jan 28, 1994 | SESE |
| K923225 | LORREX HEALTH PRODUCTS - CLINICAL MERCURY THERMOME | Lorrex Health Products | Jun 8, 1993 | SESE |
| K913793 | SIMPEX INC. ORAL AND RECTAL THERMOMETERS | Simpex, Inc. | Dec 30, 1991 | SESE |
| K911269 | MERCURY AND GLASS FEVER THERMOMETER | Steridyne Corp. | May 15, 1991 | SESE |
| K902625 | CLINICAL THERMOMETER; RECTAL/ORAL, INNER ARMPIT | Liaoning-Usa Corp. | Oct 26, 1990 | SESE |
| K903500 | MASCOT THERMOTER | Mascot, Inc. | Oct 9, 1990 | SESE |
| K901790 | THERMOMETER, MERCURY/CLINICAL | Perlink USA, Inc. | Jul 11, 1990 | SESE |
| K900646 | MERCURY THERMOMETERS (ORAL AND RECTAL) | Abel Industries, Inc. | Jul 11, 1990 | SESE |
| K897054 | CLINICAL MERCURY THERMOMETER | Cypress Medical Products, Ltd. | Mar 22, 1990 | SESE |
| K893602 | GLASS MERCURY FILLED THERMOMETERS | Smith & Nephew United, Inc. | Aug 8, 1989 | SESE |
| K883573 | THERMOMETER, MERCURY/CLINICAL | Umax Corp. | Nov 7, 1988 | SESE |
| K870285 | THERMOMETER SHEATHES, STERILE (GLASS) | The Medical Group, Inc. | Feb 12, 1987 | SESE |
| K852301 | INOX THERMOMETER JAR | Broadwest Corp. | Jul 1, 1985 | SESE |
Top Applicants
- Abco Dealers, Inc. — 3 clearances
- Abel Industries, Inc. — 1 clearance
- Airlife, Inc. — 1 clearance
- Amg Medical, Inc. — 1 clearance
- Amsia Intl., Inc. — 1 clearance
