DeviceClearance

SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM— 510(k) K092713

Substantially Equivalent

Transamerican Medical Imaging

FDA 510(k) clearance K092713 for SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM, Substantially Equivalent on 2010-07-16. Applicant: Transamerican Medical Imaging. Device class: 2.

Clearance details

Applicant
Transamerican Medical Imaging
Product code
Code IZL
Device class
Class 2
Regulation
21 CFR 892.1720
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lindon, UT, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code IZL

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Adverse events under product code IZL

product code IZL
Other
3
Total
3

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 K092713

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 K092713.

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