FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRECISION BLENDER
K Number: K053232
·
Decision Jan 10, 2006
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
54
Applicant Total
30
Review Days
53
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Basic Information
- Device Name
- PRECISION BLENDER
- K Number
- K053232
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5330
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Precision Medical, Inc.
- Date Received
- November 18, 2005
- Decision Date
- January 10, 2006
- Product Code
- BZR
- 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 |
|---|---|---|---|
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | FDA class 2 | Anesthesiology |
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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 |
| 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 |