PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX
FDA 510(k) clearance K020550 · decided 2002-08-28
Clearance details
- K-number
- K020550
- Device name
- PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX
- Applicant
- Datascope Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-02-19
- Decision date
- 2002-08-28
- Days to decision
- 190 days
- Clearance type
- Traditional
- Product code
- DSI
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mahwh, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Passport 2 with View 12 ECG Analysis Module. It is a transportable, multi-parameter physio recall (Z-0177-06) | Datascope Corp | 2005-11-23 |
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 |