MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM— 510(k) K083335
Substantially EquivalentOmnisonics Medical Technologies
FDA 510(k) clearance K083335 for MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM, Substantially Equivalent on 2008-12-15. Applicant: Omnisonics Medical Technologies. Device class: 2.
Clearance details
- Applicant
- Omnisonics Medical Technologies
- 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
- Wilmington, MA, US
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More clearances from Omnisonics Medical Technologies
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