NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System— 510(k) K153479
UnknownNinepoint Medical, Inc.
FDA 510(k) clearance K153479 for NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System, Unknown on 2016-02-16. 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
- Unknown
- Clearance type
- Traditional
- Location
- Bedford, MA, US
Recent devices under product code NQQ
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view all- K191117 — NvisionVLE Low-profile Optical Probe
- K182616 — NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
- K182261 — NvisionVLE Imaging System, NvisionVLE Optical Probe
- K143678 — NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory
- K120800 — NVISION VLE IMAGING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.