VENTURE HOME FILL II, MODEL IOH 200
FDA 510(k) clearance K003939 · decided 2001-03-21
Clearance details
- K-number
- K003939
- Device name
- VENTURE HOME FILL II, MODEL IOH 200
- Applicant
- Invacare Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-12-21
- Decision date
- 2001-03-21
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Elyria, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HomeFill Oxygen Compressor IOH200 Homefill, The serial numbers are as follows: 10JF034081, recall (Z-1423-2011) | Invacare Corporation | 2011-02-24 |