Vacumate Intermittent/Continuous CONTROLLER,VM2000
FDA 510(k) K875074 · Timeter Instrument Corp.
510(k) numberK875074
Submission
- Device name
- Vacumate Intermittent/Continuous CONTROLLER,VM2000
- Applicant
- Timeter Instrument Corp.
Lancaster, PA, US - Received
- December 9, 1987
- Decision date
- February 22, 1988
- 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 |
| K853155 | Boehringer Lab Suction InterrupterKDP · Traditional | Boehringer Laboratories | 10/16/1985SE |
| K850200 | Suction Regulator 7700 SeriesKDP · Traditional | Boehringer Laboratories | 03/04/1985SE |
| K843591 | InterceptKDP · Traditional | Vital Signs, Inc. | 10/19/1984SE |
More from Vital Signs, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K875075 | RT-200 Computer InterfaceBXX · Traditional | 04/21/1988SE |
| K871603 | Criterion II & Iia Oxygen ConcentratorsCAW · Traditional | 08/13/1987SE |
| K864836 | L.A.P. SpirometerBTY · Traditional | 03/06/1987SE |
| K834274 | Criterion ICAW · Traditional | 04/13/1984SE |
| K823775 | Bordon Gage Regulator #BgCCN · Traditional | 01/14/1983SE |
| K822746 | RT-200 Calibration AnalyzerBXX · Traditional | 10/13/1982SE |
| K812766 | PCS-5 AccessoriesBTI · Traditional | 12/17/1981SE |
| K813235 | Diss Female Air AdaptorBYK · Traditional | 12/08/1981SE |
| K813234 | Ohio Air AdaptorBYX · Traditional | 12/08/1981SE |
| K812767 | Sniff Air Compressor #SF-6BTI · Traditional | 11/27/1981SE |
Questions and answers
When was Vacumate Intermittent/Continuous CONTROLLER,VM2000 cleared by the FDA?
Vacumate Intermittent/Continuous CONTROLLER,VM2000 (K875074) received a 510(k) decision of Substantially Equivalent on February 22, 1988, 75 days after the submission was received.
What is the product code of K875074?
The FDA product code is KDP – Regulator, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 880.6740.