HAND HELD DENTAL X-RAY DEVICE— 510(k) K934818

Substantially Equivalent

Dept. of the Army

FDA 510(k) clearance K934818 for HAND HELD DENTAL X-RAY DEVICE, Substantially Equivalent on 1994-01-24. Applicant: Dept. of the Army. Device class: 2.

Clearance details

Applicant
Dept. of the Army
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
Falls Church, VA, US
Download summary PDFView on FDA.gov ↗

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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 →

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