CO2/02 MONITOR MULTINEX
FDA 510(k) clearance K872024 · decided 1988-03-31
Clearance details
- K-number
- K872024
- Device name
- CO2/02 MONITOR MULTINEX
- Applicant
- Datascope Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-05-26
- Decision date
- 1988-03-31
- Days to decision
- 310 days
- Clearance type
- Traditional
- Product code
- CCI
- Device class
- 2
- Regulation number
- 868.1690
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Paramus, NJ, 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 |
|---|---|---|
| CAPILLARY SAMPLE LINE (K771516) | Mcgaw Respiratory Therapy | 1977-08-16 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ABSORBABLE COLLAGEN HEMOSTAT (P850023/S014) | Datascope Corp. | 1994-12-22 |
| HEMOPAD(TM) ABSORBABLE COLLAGEN HEMOSTAT (P850023/S010) | Datascope Corp. | 1992-11-16 |
| ABSORBABLE COLLAGEN HEMOSTAT (P850023/S013) | Datascope Corp. | 1992-08-26 |
| HEMAFLEX (TM) MED-CHEM PRODUCTS,DISTRIBUTOR (P850023/S011) | Datascope Corp. | 1991-10-04 |
| NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S009) | Datascope Corp. | 1990-09-28 |
| NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S005) | Datascope Corp. | 1989-05-17 |
| NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S008) | Datascope Corp. | 1989-03-09 |
| NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S006) | Datascope Corp. | 1988-09-09 |