A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER
FDA 510(k) clearance K063526 · decided 2007-06-29
Clearance details
- K-number
- K063526
- Device name
- A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER
- Applicant
- A-M Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-11-22
- Decision date
- 2007-06-29
- Days to decision
- 219 days
- Clearance type
- Traditional
- Product code
- CAH
- Device class
- 2
- Regulation number
- 868.5260
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Roswell, GA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ViroMax viral/bacterial filter. The filter reduces the risk of infection due to cross-cont recall (Z-0308-2012) | A M Systems Inc | 2012-01-11 |
| Xenon Diagnostic Circuit Kits labeled as "Xenon Diagnostic Circuit", "Xenon Circuit", and recall (Z-1754-2010) | Continental Medical Labs,Inc | 2010-06-03 |