FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZEFON BATERIAL/VIRAL FILTER
K Number: K911651
·
Decision May 30, 1991
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
201
Applicant Total
4
Review Days
48
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Basic Information
- Device Name
- ZEFON BATERIAL/VIRAL FILTER
- K Number
- K911651
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5260
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Bill Olson Corp.
- Date Received
- April 12, 1991
- Decision Date
- May 30, 1991
- Product Code
- CAH
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | FDA class 2 | Anesthesiology |
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Other Clearances by Bill Olson Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K973238 | ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT WITH FILTER | Mar 11, 1998 | Substantially Equivalent |
| K935168 | ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT KITS | Feb 7, 1994 | Unknown |
| K911880 | ZEFON ADULT ANESTHESIA BREATHING CIRCUIT | Dec 20, 1991 | Substantially Equivalent |