PM3000 & PM3100 Vacuum Regulator
FDA 510(k) K922817 · Precision Medical, Inc.
510(k) numberK922817
Submission
- Device name
- PM3000 & PM3100 Vacuum Regulator
- Applicant
- Precision Medical, Inc.
Northampton, PA, US - Received
- June 11, 1992
- Decision date
- March 4, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K843591 | InterceptKDP · Traditional | Vital Signs, Inc. | 10/19/1984SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K173807 | Accu O2 Oxygen AnalyzerCCL · Abbreviated | 05/02/2018SE |
| K140179 | Easy Go VacBTA · Special | 04/25/2014SE |
| K103563 | Precision Portable Oxygen Concentration Model 4150CAW · Traditional | 07/01/2011SE |
| K103324 | Precision Liquid Oxygen SystemBYJ · Traditional | 04/21/2011SE |
| K090781 | HELIO2 BlenderBZR · Traditional | 08/13/2009SE |
| K072348 | Precision Oxygen ConcentratorCAW · Abbreviated | 10/27/2008SE |
| K063096 | Precision Oxygen MonitorCCL · Abbreviated | 02/27/2007SE |
| K053232 | Precision BlenderBZR · Traditional | 01/10/2006SE |
| K051691 | Minimate CompressorBTI · Traditional | 12/09/2005SE |
| K041122 | Precision Liquid Oxygen SystemBYJ · Traditional | 10/04/2004SE |
Questions and answers
When was PM3000 & PM3100 Vacuum Regulator cleared by the FDA?
PM3000 & PM3100 Vacuum Regulator (K922817) received a 510(k) decision of Substantially Equivalent on March 4, 1993, 266 days after the submission was received.
What is the product code of K922817?
The FDA product code is KDP – Regulator, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 880.6740.