PROGNOST ES, MODEL 0302 0000— 510(k) K011290
Substantially EquivalentXmar Corp.
FDA 510(k) clearance K011290 for PROGNOST ES, MODEL 0302 0000, Substantially Equivalent on 2001-05-30. Applicant: Xmar Corp.. Device class: 2.
Clearance details
- Applicant
- Xmar Corp.
- Product code
- Code IZF
- Device class
- Class 2
- Regulation
- 21 CFR 892.1740
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cleveland Heights, OH, US
Recent devices under product code IZF
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