OXYSHUTTLE II ,MODIFICATION
FDA 510(k) clearance K925542 · decided 1993-02-17
Clearance details
- K-number
- K925542
- Device name
- OXYSHUTTLE II ,MODIFICATION
- Applicant
- Sensor Medics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-10-19
- Decision date
- 1993-02-17
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Yorba Linda, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Critikon brand Omni-Stat Finger Sensor - P/N 009084 recall (Z-0013-04) | GE Medical Systems Information Technologies | 2003-10-15 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CUTANIOUS GAS MONITOR (P830008/S003) | Sensor Medics Corp. | 1988-02-29 |
| CUTANIOUS GAS MONITOR (P830008/S002) | Sensor Medics Corp. | 1985-01-11 |
| CUTANIOUS GAS MONITOR (P830008/S001) | Sensor Medics Corp. | 1984-10-29 |