HealthJOINT— 510(k) K202487

Substantially Equivalent

Zebra Medical Vision, Ltd.

FDA 510(k) clearance K202487 for HealthJOINT, Substantially Equivalent on 2020-12-04. Applicant: Zebra Medical Vision, Ltd.. Device class: 2.

Clearance details

Applicant
Zebra Medical Vision, Ltd.
Product code
Code LLZ
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sefayim, IL
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LLZ

product code LLZ
Death
13
Total
13

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.