ELECTROFLUIDGRAPH— 510(k) K091369
Substantially EquivalentAkern USA, LLC
FDA 510(k) clearance K091369 for ELECTROFLUIDGRAPH, Substantially Equivalent on 2009-10-14. Applicant: Akern USA, LLC. Device class: 2.
Clearance details
- Applicant
- Akern USA, LLC
- Product code
- Code MNW
- Device class
- Class 2
- Regulation
- 21 CFR 870.2770
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Greenwood Village, CO, US
Recent devices under product code MNW
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