PHILIPS INTEGRIS V5000 AND BV5000— 510(k) K973482
Substantially EquivalentPhilips Medical Systems North America, Inc.
FDA 510(k) clearance K973482 for PHILIPS INTEGRIS V5000 AND BV5000, Substantially Equivalent on 1997-11-10. Applicant: Philips Medical Systems North America, Inc..
Clearance details
- Applicant
- Philips Medical Systems North America, Inc.
- Product code
- Code IZI
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shelton, CT, US
Adverse events under product code IZI
product code IZI- Death
- 9
- Malfunction
- 5,312
- Total
- 5,321
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.