NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER— 510(k) K112770
Substantially EquivalentNinepoint Medical, Inc.
FDA 510(k) clearance K112770 for NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER, Substantially Equivalent on 2011-12-16. 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
- Traditional
- Location
- Hillsborough, CA, US
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