GREEN— 510(k) K252060

Substantially Equivalent

Phasor Health, LLC

FDA 510(k) clearance K252060 for GREEN, Substantially Equivalent on 2025-10-31. Applicant: Phasor Health, LLC.

Clearance details

Applicant: Phasor Health, LLC
Product code: Code HBE
Advisory panel: Neurology
Date received: 2025-07-01
Decision date: 2025-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HBE

product code HBE

Injury: 306
Malfunction: 7,175
Other: 1
Total: 7,482

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.