510(k) K251114
K251114 is an FDA 510(k) premarket notification submitted by Flosonics Medical for the device "FloPatch FP120". The FDA issued a decision of Substantially Equivalent on June 20, 2025. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Flosonics Medical has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 20, 2025
- Date Received
- April 11, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Flowmeter, Blood, Cardiovascular
- Device Class
- Class II
- Regulation Number
- 870.2100
- Review Panel
- CV
- Submission Type