MICROSPAN -PH MONITOR
FDA 510(k) clearance K842303 · decided 1984-10-12
Clearance details
- K-number
- K842303
- Device name
- MICROSPAN -PH MONITOR
- Applicant
- Biochem International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-06-11
- Decision date
- 1984-10-12
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- CBF
- Device class
- 2
- Regulation number
- 868.5470
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| LIFESPAN(TM) 100 TCPCO2 MONITOR (P820019/S007) | Biochem International, Inc. | 1986-03-03 |
| LIFESPAN(TM) 100 TCPCO2 MONITOR (P820019/S006) | Biochem International, Inc. | 1986-01-27 |
| LIFESPAN(TM) 100 TCPCO2 MONITOR (P820019/S005) | Biochem International, Inc. | 1985-11-19 |
| LIFESPAN(TM) MODEL 4110 TCPO2/CO2 MONITORING SYSTE (P820019/S003) | Biochem International, Inc. | 1985-08-21 |
| LIFESPAN(TM) 100 TCPCO2 MONITOR (P820019/S002) | Biochem International, Inc. | 1983-05-26 |