SOLAR SPO2 MODULE WITH MASIMO SET— 510(k) K002957
Substantially EquivalentGeneral Electric Medical Systems Information Techn
FDA 510(k) clearance K002957 for SOLAR SPO2 MODULE WITH MASIMO SET, Substantially Equivalent on 2000-10-18. Applicant: General Electric Medical Systems Information Techn.
Clearance details
- Applicant
- General Electric Medical Systems Information Techn
- Product code
- Code DQA
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Milwaukee, WI, 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.