Cleared Traditional

AVL MODEL 912 CO-OXYLITE

K895466 · Avl Scientific Corp. · Hematology
Nov 1989
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K895466 is an FDA 510(k) clearance for the AVL MODEL 912 CO-OXYLITE, a Oximeter To Measure Hemoglobin (Class II — Special Controls, product code GLY), submitted by Avl Scientific Corp. (Roswell, US). The FDA issued a Cleared decision on November 6, 1989, 56 days after receiving the submission on September 11, 1989. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7500.

Submission Details

510(k) Number K895466 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 1989
Decision Date November 06, 1989
Days to Decision 56 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GLY — Oximeter To Measure Hemoglobin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7500