PULSERA— 510(k) K061685
Substantially EquivalentPhilips Medical Systems North America Co.
FDA 510(k) clearance K061685 for PULSERA, Substantially Equivalent on 2006-09-15. Applicant: Philips Medical Systems North America Co..
Clearance details
- Applicant
- Philips Medical Systems North America Co.
- Product code
- Code IZL
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bothell, WA, US
Adverse events under product code IZL
product code IZL- Other
- 3
- Total
- 3
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.