FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FILT-R-ALL BACTERIAL/VIRAL FILTER
K Number: K900990
·
Decision Apr 19, 1990
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
201
Applicant Total
7
Review Days
48
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Basic Information
- Device Name
- FILT-R-ALL BACTERIAL/VIRAL FILTER
- K Number
- K900990
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5260
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Inhalation Plastics
- Date Received
- March 2, 1990
- Decision Date
- April 19, 1990
- 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 Inhalation Plastics
| K Number | Device Name | ||
|---|---|---|---|
| K945565 | SPIRO-FLEX | Jan 13, 1995 | Substantially Equivalent |
| K914686 | THERMO-FLOW SET | Apr 15, 1992 | Substantially Equivalent |
| K901315 | AEROMIST II NEBULIZER | Sep 10, 1990 | Substantially Equivalent |
| K900594 | ANESTHESIA BREATHING CIRCUIT | Mar 15, 1990 | Substantially Equivalent |
| K896832 | FILT-R-ALL BACTERIAL FILTER | Jan 22, 1990 | Substantially Equivalent |
| K874659 | STERILIZATION OF DEVICES BY RADIATION | Feb 2, 1988 | Substantially Equivalent |