FloPatch (FP110)
FDA 510(k) clearance K191388 · decided 2019-06-21
Clearance details
- K-number
- K191388
- Device name
- FloPatch (FP110)
- Applicant
- Flosonics Medical (R/A 1929803 Ontario Corp.)
- Decision
- Substantially Equivalent
- Date received
- 2019-05-24
- Decision date
- 2019-06-21
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- DPW
- Device class
- 2
- Regulation number
- 870.2100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Sudbury, CA
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.