DIATHRON(R) DIATHERMY UNIT— 510(k) K894513

Name: FDA 510(k) clearance K894513
Creator: U.S. Food and Drug Administration
Published: 1989-10-31

Substantially Equivalent

Intl. Ophthalmic Industries Corp.

FDA 510(k) clearance K894513 for DIATHRON(R) DIATHERMY UNIT, Substantially Equivalent on 1989-10-31. Applicant: Intl. Ophthalmic Industries Corp.. Device class: 2.

Clearance details

Applicant: Intl. Ophthalmic Industries Corp.
Product code: Code HJM
Device class: Class 2
Regulation: 21 CFR 886.1945
Advisory panel: Ophthalmic
Date received: 1989-07-19
Decision date: 1989-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weston, MA, US

Download summary PDF View on FDA.gov ↗

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