FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Accu O2 Oxygen Analyzer
K Number: K173807
·
Decision May 2, 2018
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
120
Applicant Total
30
Review Days
138
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Basic Information
- Device Name
- Accu O2 Oxygen Analyzer
- K Number
- K173807
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 868.1720
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Precision Medical, Inc.
- Date Received
- December 15, 2017
- Decision Date
- May 2, 2018
- Product Code
- CCL
- 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 |
|---|---|---|---|
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | FDA class 2 | Anesthesiology |
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Other Clearances by Precision Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K032018 | EASY PULSE II OXYGEN CONSERVER | Aug 25, 2003 | Substantially Equivalent |