FLOWGUARD DEVICE— 510(k) K013803
Substantially EquivalentBiosonix , Ltd.
FDA 510(k) clearance K013803 for FLOWGUARD DEVICE, Substantially Equivalent on 2002-02-13. Applicant: Biosonix , Ltd.. Device class: 2.
Clearance details
- Applicant
- Biosonix , Ltd.
- Product code
- Code DPW
- Device class
- Class 2
- Regulation
- 21 CFR 870.2100
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kfar Saba, IL
Recent devices under product code DPW
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