FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER
K Number: K063526
·
Decision Jun 29, 2007
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
201
Applicant Total
2
Review Days
219
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Basic Information
- Device Name
- A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER
- K Number
- K063526
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5260
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- A-M Systems, Inc.
- Date Received
- November 22, 2006
- Decision Date
- June 29, 2007
- Product Code
- CAH
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- HO
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | FDA class 2 | Anesthesiology |
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Other Clearances by A-M Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K000654 | VBMAX | Nov 14, 2000 | Substantially Equivalent |