PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A— 510(k) K063783
Substantially EquivalentPhilips Medical Systems, Inc.
FDA 510(k) clearance K063783 for PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A, Substantially Equivalent on 2007-04-27. Applicant: Philips Medical Systems, Inc..
Clearance details
- Applicant
- Philips Medical Systems, Inc.
- 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.