UNIVERSAL ABC CONTROLER— 510(k) K883580

Substantially Equivalent

Philips Medical Systems (Cleveland), Inc.

FDA 510(k) clearance K883580 for UNIVERSAL ABC CONTROLER, Substantially Equivalent on 1989-01-09. Applicant: Philips Medical Systems (Cleveland), Inc..

Clearance details

Applicant: Philips Medical Systems (Cleveland), Inc.
Product code: Code JAA
Advisory panel: Radiology
Date received: 1988-08-22
Decision date: 1989-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Highland Heights, OH, US

Download summary PDF View on FDA.gov ↗

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.