K875030

Substantially Equivalent

OCU-1

Applicant: Rudolph Beaver, Inc.
Product code: HMX
Advisory panel: Ophthalmic
Date received: 1987-12-07
Decision date: 1988-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Adverse events under product code HMX

product code HMX

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.