MIPAL
FDA 510(k) clearance K120470 · decided 2012-06-08
Clearance details
- K-number
- K120470
- Device name
- MIPAL
- Applicant
- Watermark Medical
- Decision
- Substantially Equivalent
- Date received
- 2012-02-16
- Decision date
- 2012-06-08
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- DRG
- Device class
- 2
- Regulation number
- 870.2910
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- 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.