AIRWAY FIBERSCOPES, MODELS LS-9, 0L-1, 0L-2 & PL-2— 510(k) K864821

Substantially Equivalent

Reichert-Jung, Inc.

FDA 510(k) clearance K864821 for AIRWAY FIBERSCOPES, MODELS LS-9, 0L-1, 0L-2 & PL-2, Substantially Equivalent on 1987-02-10. Applicant: Reichert-Jung, Inc..

Clearance details

Applicant: Reichert-Jung, Inc.
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 1986-12-09
Decision date: 1987-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southbridge, MA, US

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Adverse events under product code EOB

product code EOB

Malfunction: 6,143
Total: 6,143

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.