FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRESSURE RELIEF ADAPTOR
K Number: K850559
·
Decision Apr 25, 1985
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
23
Applicant Total
30
Review Days
72
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Basic Information
- Device Name
- PRESSURE RELIEF ADAPTOR
- K Number
- K850559
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2340
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Precision Medical, Inc.
- Date Received
- February 12, 1985
- Decision Date
- April 25, 1985
- Product Code
- CAX
- 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 |
|---|---|---|---|
| CAX | Flowmeter, Tube, Thorpe, Back-Pressure Compensated | FDA class 1 | Anesthesiology |
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| 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 |