MCOMPASS ANORECTAL MANOMETRY SYSTEM
FDA 510(k) clearance K120088 · decided 2012-03-29
Clearance details
- K-number
- K120088
- Device name
- MCOMPASS ANORECTAL MANOMETRY SYSTEM
- Applicant
- Medspira, LLC
- Decision
- Substantially Equivalent
- Date received
- 2012-01-11
- Decision date
- 2012-03-29
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- KLA
- Device class
- 2
- Regulation number
- 876.1725
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Minneapolis, MN, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.