FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRECISION OXYGEN CONCENTRATOR
K Number: K072348
·
Decision Oct 27, 2008
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
286
Applicant Total
30
Review Days
433
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
- PRECISION OXYGEN CONCENTRATOR
- K Number
- K072348
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 868.5440
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Precision Medical, Inc.
- Date Received
- August 21, 2007
- Decision Date
- October 27, 2008
- Product Code
- CAW
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAW | Generator, Oxygen, Portable | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAW), ordered by most recent decision date.
Portable Oxygen Concentrator
FDA 510(k)
FDA Class 2
·Anesthesiology
Oxygen Concentrator (OX-5A, OX-5C)
FDA 510(k)
FDA Class 2
·Anesthesiology
OxyGo Portable Oxygen Concentrator (1400-7000)
FDA 510(k)
FDA Class 2
·Anesthesiology
DeVilbiss 5 Liter Oxygen Concentrator (555)
FDA 510(k)
FDA Class 2
·Anesthesiology
Oxygen Concentrator (J10A)
FDA 510(k)
FDA Class 2
·Anesthesiology
Oxygen Concentrator-P2-O5E
FDA 510(k)
FDA Class 2
·Anesthesiology
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 |
| 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 |
| K032018 | EASY PULSE II OXYGEN CONSERVER | Aug 25, 2003 | Substantially Equivalent |