FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 300D HOME OXYGEN LIQUEFIER
K Number: K071461
·
Decision Aug 21, 2007
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
286
Applicant Total
2
Review Days
88
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Basic Information
- Device Name
- MODEL 300D HOME OXYGEN LIQUEFIER
- K Number
- K071461
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5440
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Copd Partners, Inc.
- Date Received
- May 25, 2007
- Decision Date
- August 21, 2007
- 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 Copd Partners, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K072011 | COPD LIQUID OXYGEN PORTABLE, MODEL 300P | Oct 18, 2007 | Substantially Equivalent |