PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A.— 510(k) K052377
Substantially EquivalentPhilips Medizin Systeme Boeblingen GmbH
FDA 510(k) clearance K052377 for PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A., Substantially Equivalent on 2005-11-17. Applicant: Philips Medizin Systeme Boeblingen GmbH.
Clearance details
- Applicant
- Philips Medizin Systeme Boeblingen GmbH
- Product code
- Code DQA
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Boeblingen, Baden-Wuerttemberg, DE
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.