STAT-SHELL DISPOSABLE SP02 SENSOR— 510(k) K000831
Substantially EquivalentEpic Medical Equipment Services, Inc.
FDA 510(k) clearance K000831 for STAT-SHELL DISPOSABLE SP02 SENSOR, Substantially Equivalent on 2000-06-05. Applicant: Epic Medical Equipment Services, Inc..
Clearance details
- Applicant
- Epic Medical Equipment Services, Inc.
- Product code
- Code DQA
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plano, TX, US
Adverse events under product code DQA
product code DQA- Death
- 66
- Malfunction
- 2,867
- Other
- 1
- Total
- 2,934
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.