SPACELABS SMART DISCLOSURE SYSTEM
FDA 510(k) clearance K110779 · decided 2011-04-19
Clearance details
- K-number
- K110779
- Device name
- SPACELABS SMART DISCLOSURE SYSTEM
- Applicant
- Spacelabs Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2011-03-21
- Decision date
- 2011-04-19
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Nederland, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Updat recall (Z-1273-2014) | Spacelabs Healthcare, Llc | 2014-03-25 |
| Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys recall (Z-0694-2013) | Spacelabs Healthcare, Llc | 2013-01-17 |