SENSOMAT
FDA 510(k) clearance K803014 · decided 1980-12-22
Clearance details
- K-number
- K803014
- Device name
- SENSOMAT
- Applicant
- Biochem International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-11-28
- Decision date
- 1980-12-22
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- CBZ
- Device class
- 2
- Regulation number
- 868.1170
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, 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.
| Record | Firm | Date |
|---|---|---|
| TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM (K020967) | Terumo Cardiovascular Systems Corp. | 2002-06-20 |
| PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR (K970906) | Diametrics Medical, Ltd. | 1997-09-23 |
| MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODI (K931112) | Puritan Bennett Corp. | 1993-06-01 |
| HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEM (K920061) | Abbott Laboratories | 1992-03-30 |
| CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED (K912030) | 3M Company | 1991-10-30 |
| PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT (K912428) | Puritan Bennett Corp. | 1991-08-09 |
| CDI(R) 2000 BLOOD GAS MONITOR (K884228) | Cardiovascular Devices, Inc. | 1989-01-30 |
| KHURI REGIONAL TISSUE PH MONITOR (K862114) | Vascular Technology Incorporated | 1986-06-25 |
| SENSOMAT MUSCLE/TISSUE PH (K803260) | Biochem International, Inc. | 1981-02-02 |
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 |