Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SnapshotNIR

K-Number: K201976 · 2020-11-10

ApplicantKent Imaging
Decision Date2020-11-10
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SnapshotNIR is a medical device manufactured by Kent Imaging. It received FDA 510(k) clearance on 2020-11-10 under approval number K201976. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SnapshotNIR?

SnapshotNIR is a medical device that received FDA 510(k) clearance on 2020-11-10. It is manufactured by Kent Imaging. The 510(k) number is K201976.

When was SnapshotNIR approved by the FDA?

SnapshotNIR received FDA 510(k) clearance on 2020-11-10, under approval number K201976.

What company makes SnapshotNIR?

SnapshotNIR is manufactured by Kent Imaging.

What is the FDA product code for SnapshotNIR?

The FDA product code for SnapshotNIR is MUD.

Related Devices (Code: MUD)

K153426Ox-Imager CSModulated Imaging, Inc. K161237HyperView Hyperspectral Tissue Oxygenation Measurement SystemHypermed Imaging, Inc. K162117NIRO-200NX DPHamamatsu Photonics K.K. K160526Masimo O3 Regional Oximeter SystemMasimo Corporation K163472Intra.Ox Handheld Tissue OximeterVioptix, Inc. K162603Masimo O3 Regional Oximeter SystemMasimo Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑