PM9000 Vac Trap
FDA 510(k) K941818 · Precision Medical, Inc.
510(k) numberK941818
Submission
- Device name
- PM9000 Vac Trap
- Applicant
- Precision Medical, Inc.
Northampton, PA, US - Received
- April 13, 1994
- Decision date
- December 12, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KDQ – Bottle, Collection, Vacuum
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
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| K932327 | Thora-Klex 350 ML Pediatric Chest Drainage SystemKDQ · Traditional | Davol, Inc. | 07/13/1993SE |
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| 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 |
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Questions and answers
When was PM9000 Vac Trap cleared by the FDA?
PM9000 Vac Trap (K941818) received a 510(k) decision of Substantially Equivalent on December 12, 1994, 243 days after the submission was received.
What is the product code of K941818?
The FDA product code is KDQ – Bottle, Collection, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 880.6740.