MAESTRO DIGITAL VIDEO SYSTEM— 510(k) K920373

Substantially Equivalent

International Imaging Electronics

FDA 510(k) clearance K920373 for MAESTRO DIGITAL VIDEO SYSTEM, Substantially Equivalent on 1992-06-24. Applicant: International Imaging Electronics. Device class: 2.

Clearance details

Applicant
International Imaging Electronics
Product code
Code IYO
Device class
Class 2
Regulation
21 CFR 892.1560
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Addison, IL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code IYO

product code IYO
Malfunction
3,339
Total
3,339

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.