ULTRAVIEW DM3 MONITOR
FDA 510(k) clearance K093802 · decided 2010-04-09
Clearance details
- K-number
- K093802
- Device name
- ULTRAVIEW DM3 MONITOR
- Applicant
- Zoe Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-12-11
- Decision date
- 2010-04-09
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Topsfield, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Numbe recall (Z-3098-2024) | Zoe Medical Incorporated | 2024-09-10 |
| Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indica recall (Z-2380-2012) | Zoe Medical Incorporated | 2012-09-14 |