Cleared Traditional

K802419 - AO NON-CONTACT II TONOMETER
(FDA 510(k) Clearance)

K802419 · American Optical Corp. · Ophthalmic

Nov 1980

Decision

37d

Days

Class 2

Risk

K802419 is an FDA 510(k) clearance for the AO NON-CONTACT II TONOMETER, a Tonometer, Ac-powered (Class II — Special Controls, product code HKX), submitted by American Optical Corp. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980, 37 days after receiving the submission on October 6, 1980. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number	K802419 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 06, 1980
Decision Date	November 12, 1980
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—