MX40 Release C.01
FDA 510(k) clearance K180017 · decided 2018-07-24
Clearance details
- K-number
- K180017
- Device name
- MX40 Release C.01
- Applicant
- Philips Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2018-01-02
- Decision date
- 2018-07-24
- Days to decision
- 203 days
- Clearance type
- Special
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
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