SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB.
FDA 510(k) clearance K915848 · decided 1992-10-28
Clearance details
- K-number
- K915848
- Device name
- SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB.
- Applicant
- Sensor Medics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-12-26
- Decision date
- 1992-10-28
- Days to decision
- 307 days
- Clearance type
- Traditional
- Product code
- DZJ
- Device class
- 2
- Regulation number
- 872.4120
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Yorba Linda, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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 |