FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0
K Number: K021082
·
Decision May 22, 2002
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
286
Applicant Total
9
Review Days
49
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Basic Information
- Device Name
- ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0
- K Number
- K021082
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5440
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- On Site Gas Systems, Inc.
- Date Received
- April 3, 2002
- Decision Date
- May 22, 2002
- 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 |
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Other Clearances by On Site Gas Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K092636 | POGS, MODEL 65/130 | Jan 7, 2010 | Substantially Equivalent |
| K063454 | POGS, MODEL 33C | May 9, 2007 | Substantially Equivalent |
| K041664 | PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C | Jul 29, 2004 | Substantially Equivalent |
| K030920 | POGS 33 | Mar 10, 2004 | Substantially Equivalent |
| K021581 | HEMOSORB | Jul 12, 2002 | Substantially Equivalent |
| K013390 | QUICKCLOT | May 23, 2002 | Substantially Equivalent |
| K020362 | P.O.G.S. 3.3 PORTABLE OXYGEN GENERATOR SYSTEM | Feb 12, 2002 | Substantially Equivalent |
| K014078 | ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM | Jan 8, 2002 | Substantially Equivalent |