FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RCI VIRAL/BACTERIAL FILTER
K Number: K892230
·
Decision Aug 28, 1989
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
201
Applicant Total
26
Review Days
146
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Basic Information
- Device Name
- RCI VIRAL/BACTERIAL FILTER
- K Number
- K892230
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5260
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Respiratory Care, Inc.
- Date Received
- April 4, 1989
- Decision Date
- August 28, 1989
- 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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|---|---|---|---|
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| K834151 | CONCHATHERM LHF HUMIDIFIER HEATER | Jan 13, 1984 | Substantially Equivalent |
| K833974 | AQUAPAK 020 HUMIDIFIER ADAPTER | Dec 16, 1983 | Substantially Equivalent |
| K832453 | SLIMB SINGLE LIMB BREATHING CIRCUIT | Oct 27, 1983 | Substantially Equivalent |
| K811524 | AQUACADE | Jul 1, 1981 | Substantially Equivalent |
| K811073 | A QUAPAK | Apr 29, 1981 | Substantially Equivalent |