CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box— 510(k) K152582
Substantially EquivalentVolcano Corporation
FDA 510(k) clearance K152582 for CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box, Substantially Equivalent on 2015-12-03. Applicant: Volcano Corporation. Device class: 2.
Clearance details
- Applicant
- Volcano Corporation
- Product code
- Code DSK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1110
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Diego, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.