NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System— 510(k) K182616
UnknownNinepoint Medical, Inc.
FDA 510(k) clearance K182616 for NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System, Unknown on 2018-11-02. 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
- Unknown
- Clearance type
- Traditional
- Location
- Bedford, MA, US
Recent devices under product code NQQ
view allMore clearances from Ninepoint Medical, Inc.
view all- K191117 — NvisionVLE Low-profile Optical Probe
- K182261 — NvisionVLE Imaging System, NvisionVLE Optical Probe
- K153479 — NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System
- K143678 — NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory
- K120800 — NVISION VLE IMAGING SYSTEM
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