FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLOW CONTROLLER
K Number: K843223
·
Decision Sep 27, 1984
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
208
Applicant Total
30
Review Days
42
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Basic Information
- Device Name
- FLOW CONTROLLER
- K Number
- K843223
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5915
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Precision Medical, Inc.
- Date Received
- August 16, 1984
- Decision Date
- September 27, 1984
- Product Code
- BTM
- 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 |
|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | FDA class 2 | Anesthesiology |
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FDA 510(k)
FDA Class 2
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|---|---|---|---|
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| 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 |