MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE
FDA 510(k) clearance K011536 · decided 2001-11-14
Clearance details
- K-number
- K011536
- Device name
- MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE
- Applicant
- Oridion Medical 1987 , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2001-05-18
- Decision date
- 2001-11-14
- Days to decision
- 180 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 O2 ADU/INT 25UN Part Number: 009822 Oridion 3012176-012 P recall (Z-2004-2010) | Oridion Medical 1987 Ltd. | 2010-07-13 |
| Microstream SMART CAPNOLINE PLUS O2 LONG ADU/INT 25UN Part Number: 009826 recall (Z-2005-2010) | Oridion Medical 1987 Ltd. | 2010-07-13 |
| Microstream SMART CAPNOLINE PLUS O2 100UN Part Number: 010210 Oridion 3012176-112 Physio C recall (Z-2007-2010) | Oridion Medical 1987 Ltd. | 2010-07-13 |
| Microstream SMART CAPNOLINE H PLUS O2 ADU/INT 25UN Part Number: 010433 recall (Z-2008-2010) | Oridion Medical 1987 Ltd. | 2010-07-13 |
| Microstream SCP H PLUS O2 ADU/INT 100UN Part Number: 010625 recall (Z-2009-2010) | Oridion Medical 1987 Ltd. | 2010-07-13 |
| Microstream SMART CAPNOLINE PLUS O2 LONG 100 UN Part Number: 010341 010341 Part Number: 10 recall (Z-2013-2010) | Oridion Medical 1987 Ltd. | 2010-07-13 |