ENDEAVOUR MONITORING SYSTEM
FDA 510(k) clearance K102004 · decided 2010-09-10
Clearance details
- K-number
- K102004
- Device name
- ENDEAVOUR MONITORING SYSTEM
- Applicant
- Mindray DS USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-07-15
- Decision date
- 2010-09-10
- Days to decision
- 57 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 |
|---|---|---|
| Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product Usage: The recall (Z-0389-2014) | Mindray DS USA, Inc. dba Mindray North America | 2013-11-25 |
| Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in Chi recall (Z-0528-2013) | Mindray DS USA, Inc. d.b.a. Mindray North America | 2012-12-17 |
| V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is int recall (Z-2279-2012) | Mindray DS USA, Inc. d.b.a. Mindray North America | 2012-08-28 |