510(k) K191388
K191388 is an FDA 510(k) premarket notification submitted by Flosonics Medical (R/A 1929803 Ontario Corp.) for the device "FloPatch (FP110)". The FDA issued a decision of Substantially Equivalent on June 21, 2019. 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
- June 21, 2019
- Date Received
- May 24, 2019
- 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