Cleared Traditional

KAMPPETER ANOMALOSCOPE

K930575 · Bova Intl. · Ophthalmic
Feb 1994
Decision
386d
Days
Class 1
Risk

About This 510(k) Submission

K930575 is an FDA 510(k) clearance for the KAMPPETER ANOMALOSCOPE, a Anomaloscope (Class I — General Controls, product code HIW), submitted by Bova Intl. (Fort Worth, US). The FDA issued a Cleared decision on February 25, 1994, 386 days after receiving the submission on February 4, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1070.

Submission Details

510(k) Number K930575 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 1993
Decision Date February 25, 1994
Days to Decision 386 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HIW — Anomaloscope
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1070