ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV.— 510(k) K893476

Substantially Equivalent

Andros Analyzers, Inc.

FDA 510(k) clearance K893476 for ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV., Substantially Equivalent on 1989-06-23. Applicant: Andros Analyzers, Inc..

Clearance details

Applicant: Andros Analyzers, Inc.
Product code: Code JAA
Advisory panel: Radiology
Date received: 1989-05-04
Decision date: 1989-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berkeley, CA, US

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Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.