OPMI MD SURGICAL MICROSCOPE— 510(k) K874241

Substantially Equivalent

Carl Zeiss, Inc.

FDA 510(k) clearance K874241 for OPMI MD SURGICAL MICROSCOPE, Substantially Equivalent on 1987-12-23. Applicant: Carl Zeiss, Inc..

Clearance details

Applicant: Carl Zeiss, Inc.
Product code: Code FSO
Advisory panel: General, Plastic Surgery
Date received: 1987-10-15
Decision date: 1987-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thornwood, NY, US

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Adverse events under product code FSO

product code FSO

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.