HP-FAST— 510(k) K944903

Substantially Equivalent

Gi Supply

FDA 510(k) clearance K944903 for HP-FAST, Substantially Equivalent on 1995-04-20. Applicant: Gi Supply.

Clearance details

Applicant: Gi Supply
Product code: Code LYR
Advisory panel: Microbiology
Date received: 1994-10-04
Decision date: 1995-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camp Hill, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LYR

product code LYR

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.