2200I PHYSIOLOGICAL MONITOR
FDA 510(k) clearance K863308 · decided 1987-01-02
Clearance details
- K-number
- K863308
- Device name
- 2200I PHYSIOLOGICAL MONITOR
- Applicant
- Datascope Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-08-25
- Decision date
- 1987-01-02
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- DXG
- Device class
- 2
- Regulation number
- 870.1435
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Paramus, NJ, US
- Third-party review
- No
- Expedited review
- No
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| EV1000 Clinical Platform (K193179) | Edwards Lifesciences, LLC | 2019-12-17 |
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| Argos (K181372) | Retia Medical, LLC | 2018-12-13 |
| PulsioFlex Monitoring System (K172259) | Pulsion Medical Systems SE | 2018-01-18 |
| LiDCOunity v2 Hemodynamic Monitor (K163334) | Lidco, Ltd. | 2017-06-05 |
| LiDCOunity Monitor (K152935) | Lidco, Ltd. | 2016-03-17 |
| TRANSONIC ELSA SYSTEM (K134051) | Transonic Systems, Inc. | 2015-01-29 |
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 |