PHILLIPS EASY VISION FAMILY WORKSTATION OPTION ENDO 3D— 510(k) K973983
Substantially EquivalentPhilips Medical Systems, Inc.
FDA 510(k) clearance K973983 for PHILLIPS EASY VISION FAMILY WORKSTATION OPTION ENDO 3D, Substantially Equivalent on 1998-01-08. Applicant: Philips Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems, Inc.
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shelton, CT, US
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Adverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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.