TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH)— 510(k) K042099

Name: FDA 510(k) clearance K042099
Creator: U.S. Food and Drug Administration
Published: 2004-12-10

Substantially Equivalent

Retinapharma Technologies, Inc.

FDA 510(k) clearance K042099 for TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH), Substantially Equivalent on 2004-12-10. Applicant: Retinapharma Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Retinapharma Technologies, Inc.
Product code: Code HKX
Device class: Class 2
Regulation: 21 CFR 886.1930
Advisory panel: Ophthalmic
Date received: 2004-08-04
Decision date: 2004-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rydal, PA, US

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