FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PM9000 VAC TRAP
K Number: K941818
·
Decision Dec 12, 1994
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
47
Applicant Total
30
Review Days
243
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PM9000 VAC TRAP
- K Number
- K941818
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Precision Medical, Inc.
- Date Received
- April 13, 1994
- Decision Date
- December 12, 1994
- Product Code
- KDQ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KDQ | Bottle, Collection, Vacuum | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KDQ), ordered by most recent decision date.
EXPRESS CHEST DRAIN
FDA 510(k)
FDA Class 2
·General Hospital
MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
OCEAN CHEST DRAIN
FDA 510(k)
FDA Class 2
·General Hospital
ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN
FDA 510(k)
FDA Class 2
·General Hospital
PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR
FDA 510(k)
FDA Class 2
·General Hospital
ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Precision Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K173807 | Accu O2 Oxygen Analyzer | May 2, 2018 | Substantially Equivalent |
| K140179 | EASY GO VAC | Apr 25, 2014 | Substantially Equivalent |
| K103563 | PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150 | Jul 1, 2011 | Substantially Equivalent |
| K103324 | PRECISION LIQUID OXYGEN SYSTEM | Apr 21, 2011 | Substantially Equivalent |
| K090781 | HELIO2 BLENDER | Aug 13, 2009 | Substantially Equivalent |
| K072348 | PRECISION OXYGEN CONCENTRATOR | Oct 27, 2008 | Substantially Equivalent |
| K063096 | PRECISION OXYGEN MONITOR | Feb 27, 2007 | Substantially Equivalent |
| K053232 | PRECISION BLENDER | Jan 10, 2006 | Substantially Equivalent |
| K051691 | MINIMATE COMPRESSOR | Dec 9, 2005 | Substantially Equivalent |
| K041122 | PRECISION LIQUID OXYGEN SYSTEM | Oct 4, 2004 | Substantially Equivalent |