Cleared Traditional

K781173 - COMPUTER INTERFACE IL 814 (FDA 510(k) Clearance)

Sep 1978
Decision
63d
Days
Class 1
Risk

K781173 is an FDA 510(k) clearance for the COMPUTER INTERFACE IL 814. This device is classified as a Calculator/data Processing Module, For Clinical Use (Class I - General Controls, product code JQP).

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on September 14, 1978, 63 days after receiving the submission on July 13, 1978.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2100.

Submission Details

510(k) Number K781173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1978
Decision Date September 14, 1978
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

Product Code JQP — Calculator/data Processing Module, For Clinical Use
Device Class Class I - General Controls
CFR Regulation 21 CFR 862.2100