MODIFIED OXYGEN DELIVERY/CO2 SAMPLE NASAL CANNULA
FDA 510(k) clearance K892406 · decided 1989-07-24
Clearance details
- K-number
- K892406
- Device name
- MODIFIED OXYGEN DELIVERY/CO2 SAMPLE NASAL CANNULA
- Applicant
- Salter Labs
- Decision
- Substantially Equivalent
- Date received
- 1989-04-07
- Decision date
- 1989-07-24
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- CCK
- Device class
- 2
- Regulation number
- 868.1400
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Arvin, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube recall (Z-1898-2012) | SALTER LABS | 2012-06-27 |
| ETCO2 Divided Sampling Cannula with Simultaneous Oxygen Delivery, Model number 4707 7-7-24 recall (Z-0605-2012) | SALTER LABS | 2012-01-11 |
| Nasal Cannula (Adult) Salter Style with modified nasal prongs, 7" (2.1M) Q supply tube and recall (Z-2237-2011) | Salter Laboratories, Division of Regulatory Affairs | 2011-05-20 |