FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VENTURE HOMEFILL II WITH OXYGEN CONSERVER
K Number: K021685
·
Decision Jul 23, 2002
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
273
Applicant Total
111
Review Days
62
Basic Information
- Device Name
- VENTURE HOMEFILL II WITH OXYGEN CONSERVER
- K Number
- K021685
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5440
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- INVACARE CORP.
- Date Received
- May 22, 2002
- Decision Date
- July 23, 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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