MICROSTREAM ORAL NASAL CANNULA FILTERLINE
FDA 510(k) clearance K011050 · decided 2001-05-04
Clearance details
- K-number
- K011050
- Device name
- MICROSTREAM ORAL NASAL CANNULA FILTERLINE
- Applicant
- Oridion Medical 1987 , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2001-04-06
- Decision date
- 2001-05-04
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- CCK
- Device class
- 2
- Regulation number
- 868.1400
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Jerusalem, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Oridion CO2 sampling lines and water traps under the label: MicroStreamC02 Sampling Lines: recall (Z-1332-2012) | Oridion Medical 1987 Ltd. | 2012-03-29 |
| Microstream SMART CAPNOLINE PLUS ADU/INT 25UN Part Number: 009818 Oridion 3012176-011 Phys recall (Z-2003-2010) | Oridion Medical 1987 Ltd. | 2010-07-13 |
| Microstream SMART CAPNOLINE PLUS 100 UN Part Number: 010209 Oridion 3012176-111 Physio Con recall (Z-2006-2010) | Oridion Medical 1987 Ltd. | 2010-07-13 |