SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION— 510(k) K962811
Substantially EquivalentSpacelabs Medical, Inc.
FDA 510(k) clearance K962811 for SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION, Substantially Equivalent on 1997-06-24. Applicant: Spacelabs Medical, Inc..
Clearance details
- Applicant
- Spacelabs Medical, Inc.
- Product code
- Code DXJ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redmond, WA, US
Adverse events under product code DXJ
product code DXJ- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.