AN1036 Dosimeter— 510(k) K200334

Substantially Equivalent

Andersen Sterilizers, Inc.

FDA 510(k) clearance K200334 for AN1036 Dosimeter, Substantially Equivalent on 2020-11-12. Applicant: Andersen Sterilizers, Inc.. Device class: 2.

Clearance details

Applicant: Andersen Sterilizers, Inc.
Product code: Product code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2020-02-11
Decision date: 2020-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haw River, NC, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.