Millenium HX
FDA 510(k) clearance K192398 · decided 2019-10-03
Clearance details
- K-number
- K192398
- Device name
- Millenium HX
- Applicant
- Mar Cor Purification, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-09-03
- Decision date
- 2019-10-03
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- FIP
- Device class
- 2
- Regulation number
- 876.5665
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.