REGALTECH MAXISCOPE— 510(k) K921163

Substantially Equivalent

Regaltech Pty. , Ltd.

FDA 510(k) clearance K921163 for REGALTECH MAXISCOPE, Substantially Equivalent on 1992-10-27. Applicant: Regaltech Pty. , Ltd.. Device class: 2.

Clearance details

Applicant: Regaltech Pty. , Ltd.
Product code: Code HLI
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 1992-03-11
Decision date: 1992-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Western Australia, AU

Download summary PDF View on FDA.gov ↗

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