DeviceClearance

MODEL I-2000 MONITOR— 510(k) K072382

Substantially Equivalent

Infinite Biomedical Technologies

FDA 510(k) clearance K072382 for MODEL I-2000 MONITOR, Substantially Equivalent on 2008-02-15. Applicant: Infinite Biomedical Technologies. Device class: 2.

Clearance details

Applicant
Infinite Biomedical Technologies
Product code
Code OLT
Device class
Class 2
Regulation
21 CFR 882.1400
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Baltimore, MD, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code OLT

product code OLT
Other
1
Total
1

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.