FloPatch (FP120)
FDA 510(k) clearance K200337 · decided 2020-03-24
Clearance details
- K-number
- K200337
- Device name
- FloPatch (FP120)
- Applicant
- Flosonics Medical (R/A 1929803 Ontario Corp.)
- Decision
- Substantially Equivalent
- Date received
- 2020-02-11
- Decision date
- 2020-03-24
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- DPW
- Device class
- 2
- Regulation number
- 870.2100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Toronto, CA
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FloPatch FP120, REF: FP120-FOT01-005 recall (Z-2517-2025) | Flosonics Medical (R/A 1929803 ONTARIO CORP.) | 2025-09-04 |