CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED
FDA 510(k) clearance K912030 · decided 1991-10-30
Clearance details
- K-number
- K912030
- Device name
- CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED
- Applicant
- 3M Company
- Decision
- Substantially Equivalent
- Date received
- 1991-05-07
- Decision date
- 1991-10-30
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- CBZ
- Device class
- 2
- Regulation number
- 868.1170
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Tustin, CA, 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 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S011) | 3M Company | 1994-11-28 |
| CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S010) | 3M Company | 1994-05-19 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S006) | 3M Company | 1992-12-31 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S009) | 3M Company | 1992-03-13 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S008) | 3M Company | 1992-01-28 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S007) | 3M Company | 1990-10-17 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S005) | 3M Company | 1990-03-08 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S004) | 3M Company | 1989-11-22 |