Fever Meter
FDA 510(k) K821314 · Steridyne Corp.
510(k) numberK821314
Submission
- Device name
- Fever Meter
- Applicant
- Steridyne Corp.
Walker, MI, US - Received
- May 4, 1982
- Decision date
- May 28, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KDP – Regulator, Vacuum
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
Other 510(k)s with product code KDP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K013976 | Boehringer MRI Suction RegulatoryKDP · Traditional | Boehringer Laboratories | 01/08/2002SE |
| K944479 | PM3300 Intermittent VacuumKDP · Traditional | Precision Medical, Inc. | 12/22/1994SE |
| K942747 | Malcolm-Lynn(Tm) Eot Suction Reg Valve(Tm) (SRV) )KDP · Traditional | Engineered Orthopedic Technologies, Inc. | 07/21/1994SE |
| K933232 | Boehringer Laboratories Suction Regulator, ModifiedKDP · Traditional | Boehringer Laboratories | 03/28/1994SE |
| K926140 | Vacuum Power Body Fluid Suction ApparatusKDP · Traditional | Hill-Rom, Inc. | 07/27/1993SE |
| K922817 | PM3000 & PM3100 Vacuum RegulatorKDP · Traditional | Precision Medical, Inc. | 03/04/1993SE |
| K883229 | Ohmeda Continuous Suction RegulatorKDP · Traditional | Ohmeda Medical | 10/19/1988SE |
| K875074 | Vacumate Intermittent/Continuous CONTROLLER,VM2000KDP · Traditional | Timeter Instrument Corp. | 02/22/1988SE |
| K853155 | Boehringer Lab Suction InterrupterKDP · Traditional | Boehringer Laboratories | 10/16/1985SE |
| K850200 | Suction Regulator 7700 SeriesKDP · Traditional | Boehringer Laboratories | 03/04/1985SE |
More from Boehringer Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K925352 | Clean Cuff Blood Pressure Cuff LinerDXQ · Traditional | 01/12/1993SE |
| K911843 | Zero-G(Tm) Gel/Foam Mattress TopperKIC · Traditional | 05/30/1991SE |
| K911269 | Mercury and Glass Fever ThermometerFLK · Traditional | 05/15/1991SE |
| K842120 | Zero-GKIC · Traditional | 06/08/1984SE |
| K801458 | Winter Head DressingFQM · Traditional | 07/28/1980SE |
Questions and answers
When was Fever Meter cleared by the FDA?
Fever Meter (K821314) received a 510(k) decision of Substantially Equivalent on May 28, 1982, 24 days after the submission was received.
What is the product code of K821314?
The FDA product code is KDP – Regulator, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 880.6740.