VIEWPOINT TELEMETRY SYSTEM
FDA 510(k) clearance K031760 · decided 2003-10-10
Clearance details
- K-number
- K031760
- Device name
- VIEWPOINT TELEMETRY SYSTEM
- Applicant
- Datascope Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-06-06
- Decision date
- 2003-10-10
- Days to decision
- 126 days
- Clearance type
- Abbreviated
- Product code
- MHX
- 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 |
|---|---|---|
| Panaroma Central Station Product Usage: This device can view real time, store, print, grap recall (Z-1156-2014) | Mindray DS USA, Inc. dba Mindray North America | 2014-03-07 |
| Panorama Patient Monitoring Network with ambulatory telepacks, and software version 8.5.5, recall (Z-1401-2009) | Mindray DS USA, Inc., dba Datascope Patient Monitoring | 2009-05-27 |
| Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor. recall (Z-0437-06) | Datascope Corp | 2006-01-24 |
| Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor. recall (Z-1567-05) | Datascope Corp | 2005-09-21 |
| Panorama Patient Monitoring Network. Cardiac Arrhythmia Monitor. recall (Z-1104-05) | Datascope Corp | 2005-08-06 |
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 |