510(k) K200337
K200337 is an FDA 510(k) premarket notification submitted by Flosonics Medical (R/A 1929803 Ontario Corp.) for the device "FloPatch (FP120)". The FDA issued a decision of Substantially Equivalent on March 24, 2020. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Flosonics Medical (R/A 1929803 Ontario Corp.) has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 2020
- Date Received
- February 11, 2020
- 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