INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM— 510(k) K890509

Substantially Equivalent

Biophysic Medical, Inc.

FDA 510(k) clearance K890509 for INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM, Substantially Equivalent on 1989-03-24. Applicant: Biophysic Medical, Inc..

Clearance details

Applicant: Biophysic Medical, Inc.
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 1989-02-01
Decision date: 1989-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasant Hill, CA, US

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Adverse events under product code HQF

product code HQF

Injury: 166
Other: 1
Total: 167

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.