Cleared Traditional

RICA (DIAGNOSTIC INSTRUMENTS)

K810054 · Robert I. Chien & Assoc., Inc. · Neurology
Jan 1981
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K810054 is an FDA 510(k) clearance for the RICA (DIAGNOSTIC INSTRUMENTS), a Percussor (Class I — General Controls, product code GWZ), submitted by Robert I. Chien & Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1981, 16 days after receiving the submission on January 12, 1981. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1700.

Submission Details

510(k) Number K810054 FDA.gov
FDA Decision Cleared SESE
Date Received January 12, 1981
Decision Date January 28, 1981
Days to Decision 16 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code GWZ — Percussor
Device Class Class I — General Controls
CFR Regulation 21 CFR 882.1700