EndoWave Infusion System— 510(k) K080392
Substantially EquivalentEkos Corp.
FDA 510(k) clearance K080392 for EndoWave Infusion System, Substantially Equivalent on 2008-04-30. Applicant: Ekos Corp.. Device class: 2.
Clearance details
- Applicant
- Ekos Corp.
- Product code
- Code QEY
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bothell, WA, US
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More clearances from Ekos Corp.
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