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510(k) K042099

TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH) by Retinapharma Technologies, Inc. — Product Code HKX

K042099 is an FDA 510(k) premarket notification submitted by Retinapharma Technologies, Inc. for the device "TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH)". The FDA issued a decision of Substantially Equivalent on December 10, 2004. The device falls under product code HKX (Tonometer, Ac-Powered), a Class II device regulated under 21 CFR 886.1930.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2004
Date Received
August 4, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tonometer, Ac-Powered
Device Class
Class II
Regulation Number
886.1930
Review Panel
OP
Submission Type

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FDA data resources