DI-RHEX OPHTHALMIC DIATHERMY SYSTEM— 510(k) K990064

Name: FDA 510(k) clearance K990064
Creator: U.S. Food and Drug Administration
Published: 1999-04-04

Substantially Equivalent

Ophthalmic Technologies, Inc.

FDA 510(k) clearance K990064 for DI-RHEX OPHTHALMIC DIATHERMY SYSTEM, Substantially Equivalent on 1999-04-04. Applicant: Ophthalmic Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Ophthalmic Technologies, Inc.
Product code: Code HQR
Device class: Class 2
Regulation: 21 CFR 886.4100
Advisory panel: Ophthalmic
Date received: 1999-01-08
Decision date: 1999-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Downsview, Ontario, CA

Download summary PDF View on FDA.gov ↗

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