Waterless Seal & Vacuum Regulator
FDA 510(k) K820706 · Sorensen Research
510(k) numberK820706
Submission
- Device name
- Waterless Seal & Vacuum Regulator
- Applicant
- Sorensen Research
Walker, MI, US - Received
- March 16, 1982
- Decision date
- April 9, 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 |
|---|---|---|
| K833674 | Accurate Measurement Device Kg-AmdGCX · Traditional | 01/25/1984SE |
| K833673 | Accurate Measurement Device Ez-AmdGCX · Traditional | 12/29/1983SE |
| K833096 | Transducer Dome DS106DRS · Traditional | 11/03/1983SE |
| K833095 | Transducer Dome SD105DRS · Traditional | 11/03/1983SE |
| K833094 | Transducer Dome SD104DRS · Traditional | 11/03/1983SE |
| K832957 | Flow-Directed Heparin Coated ThermodilDYG · Traditional | 09/29/1983SE |
| K831506 | Disp. Transducer W/Monitoring Kit TransDRS · Traditional | 08/12/1983SE |
| K831939 | Tall Floor Stand TFS-01GCX · Traditional | 07/19/1983SE |
| K831505 | Thoracic Gauge #TG-60 -Vacuum RegulatorKDP · Traditional | 07/12/1983SE |
| K813464 | Disposable TransducerDRS · Traditional | 01/07/1982SE |
Questions and answers
When was Waterless Seal & Vacuum Regulator cleared by the FDA?
Waterless Seal & Vacuum Regulator (K820706) received a 510(k) decision of Substantially Equivalent on April 9, 1982, 24 days after the submission was received.
What is the product code of K820706?
The FDA product code is KDP – Regulator, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 880.6740.