ApexM
FDA 510(k) clearance K150183 · decided 2015-04-09
Clearance details
- K-number
- K150183
- Device name
- ApexM
- Applicant
- Incontrol Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-01-27
- Decision date
- 2015-04-09
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- KPI
- Device class
- 2
- Regulation number
- 876.5320
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Brookfield, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.