DeviceClearance

SnapshotNIR— 510(k) K201976

Substantially Equivalent

Kent Imaging

FDA 510(k) clearance K201976 for SnapshotNIR, Substantially Equivalent on 2020-11-10. Applicant: Kent Imaging. Device class: 2.

Clearance details

Applicant
Kent Imaging
Product code
Code MUD
Device class
Class 2
Regulation
21 CFR 870.2700
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Calgary, CA
Download summary PDFView on FDA.gov ↗

Recent devices under product code MUD

view all

Adverse events under product code MUD

product code MUD
Malfunction
467
Total
467

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K201976

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201976.

Data sourced from openFDA. This site is unofficial and independent of the FDA.