Ohmeda Continuous Suction Regulator
FDA 510(k) K883229 · Ohmeda Medical
510(k) numberK883229
Submission
- Device name
- Ohmeda Continuous Suction Regulator
- Applicant
- Ohmeda Medical
Columbia, MD, US - Received
- August 1, 1988
- Decision date
- October 19, 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 |
| 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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| K072157 | Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)FMT · Special | 08/27/2007SE |
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| K070247 | Giraffe and Panda Bag and Mask Resuscitation SystemBTM · Traditional | 04/20/2007SE |
| K070210 | Giraffe and Panda T- Piece Resuscitation SystemBTL · Traditional | 04/20/2007SE |
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Questions and answers
When was Ohmeda Continuous Suction Regulator cleared by the FDA?
Ohmeda Continuous Suction Regulator (K883229) received a 510(k) decision of Substantially Equivalent on October 19, 1988, 79 days after the submission was received.
What is the product code of K883229?
The FDA product code is KDP – Regulator, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 880.6740.