Cleared Traditional

FLUOROSCAN NEONATAL

K950415 · Isolab, Inc. · Chemistry
Sep 1995
Decision
217d
Days
Class 1
Risk

About This 510(k) Submission

K950415 is an FDA 510(k) clearance for the FLUOROSCAN NEONATAL, a Fluorometer, For Clinical Use (Class I — General Controls, product code KHO), submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on September 5, 1995, 217 days after receiving the submission on January 31, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2560.

Submission Details

510(k) Number K950415 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 1995
Decision Date September 05, 1995
Days to Decision 217 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code KHO — Fluorometer, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2560

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