NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER— 510(k) K121195
Substantially EquivalentNinepoint Medical, Inc.
FDA 510(k) clearance K121195 for NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER, Substantially Equivalent on 2012-07-25. Applicant: Ninepoint Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Ninepoint Medical, Inc.
- Product code
- Code NQQ
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hillsborough, CA, US
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