EZ-MISTER— 510(k) K093584

Substantially Equivalent

N.M. Beale Co., Inc.

FDA 510(k) clearance K093584 for EZ-MISTER, Substantially Equivalent on 2011-03-04. Applicant: N.M. Beale Co., Inc..

Clearance details

Applicant: N.M. Beale Co., Inc.
Product code: Code CCT
Advisory panel: Anesthesiology
Date received: 2009-11-19
Decision date: 2011-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ayer, MA, US

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Adverse events under product code CCT

product code CCT

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.