PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR
FDA 510(k) clearance K970906 · decided 1997-09-23
Clearance details
- K-number
- K970906
- Device name
- PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR
- Applicant
- Diametrics Medical, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1997-03-12
- Decision date
- 1997-09-23
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- CBZ
- Device class
- 2
- Regulation number
- 868.1170
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- High Wycombe, Buckinghamshire, GB
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM (K020967) | Terumo Cardiovascular Systems Corp. | 2002-06-20 |
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| 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 |
| SENSOMAT (K803014) | Biochem International, Inc. | 1980-12-22 |
Recalls involving this device
No recalls on record reference this clearance.