CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
FDA 510(k) clearance K152582 · decided 2015-12-03
Clearance details
- K-number
- K152582
- Device name
- CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
- Applicant
- Volcano Corporation
- Decision
- Substantially Equivalent
- Date received
- 2015-09-10
- Decision date
- 2015-12-03
- Days to decision
- 84 days
- Clearance type
- Special
- Product code
- DSK
- Device class
- 2
- Regulation number
- 870.1110
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.