MINNCARE HD
FDA 510(k) clearance K133724 · decided 2014-08-27
Clearance details
- K-number
- K133724
- Device name
- MINNCARE HD
- Applicant
- Medivators, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-12-06
- Decision date
- 2014-08-27
- Days to decision
- 264 days
- Clearance type
- Traditional
- Product code
- NIH
- 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.