MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03— 510(k) K062268
Substantially EquivalentPhilips Medical Systems North America Co.
FDA 510(k) clearance K062268 for MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03, Substantially Equivalent on 2006-10-18. Applicant: Philips Medical Systems North America Co..
Clearance details
- Applicant
- Philips Medical Systems North America Co.
- Product code
- Code DQA
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Andover, MA, 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.