Cleared Traditional

SnapshotNIR model KD205

K240601 · Kent Imaging, Inc. · General & Plastic Surgery
Apr 2024
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K240601 is an FDA 510(k) clearance for the SnapshotNIR model KD205, a Oximeter, Tissue Saturation (Class II — Special Controls, product code MUD), submitted by Kent Imaging, Inc. (Calgary, CA). The FDA issued a Cleared decision on April 2, 2024, 29 days after receiving the submission on March 4, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K240601 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2024
Decision Date April 02, 2024
Days to Decision 29 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code MUD — Oximeter, Tissue Saturation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700