SR SUITE 1.0— 510(k) K121345

Substantially Equivalent

Halifax Biomedical, Inc.

FDA 510(k) clearance K121345 for SR SUITE 1.0, Substantially Equivalent on 2012-06-01. Applicant: Halifax Biomedical, Inc..

Clearance details

Applicant: Halifax Biomedical, Inc.
Product code: Code KPR
Advisory panel: Radiology
Date received: 2012-05-04
Decision date: 2012-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.