FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
FloPatch FP120
K Number: K222242
·
Decision Dec 9, 2022
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
134
Applicant Total
3
Review Days
136
Basic Information
- Device Name
- FloPatch FP120
- K Number
- K222242
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Flosonics Medical
- Date Received
- July 26, 2022
- Decision Date
- December 9, 2022
- Product Code
- DPW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DPW), ordered by most recent decision date.
FloPatch FP120
FDA 510(k)
FDA Class 2
·Cardiovascular
Elfor-L
FDA 510(k)
FDA Class 2
·Cardiovascular
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)
FDA 510(k)
FDA Class 2
·Cardiovascular
FloPatch FP120
FDA 510(k)
FDA Class 2
·Cardiovascular
GEM FLOW COUPLER Monitor (GEM1020M-2)
FDA 510(k)
FDA Class 2
·Cardiovascular
VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger
FDA 510(k)
FDA Class 2
·Cardiovascular