ivi N3003 Surgical face Mask, ivi N6006 Surgical mask— 510(k) K201896

Substantially Equivalent

Iob Medical, Inc.

FDA 510(k) clearance K201896 for ivi N3003 Surgical face Mask, ivi N6006 Surgical mask, Substantially Equivalent on 2021-03-30. Applicant: Iob Medical, Inc..

Clearance details

Applicant: Iob Medical, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2020-07-08
Decision date: 2021-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

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.