Cleared Traditional

K760208 - OXIMETER, CO-, IL MODEL 282 (FDA 510(k) Clearance)

K760208 · Instrumentation Laboratory CO · Hematology device

Jul 1976

Decision

17d

Days

Class 2

Risk

K760208 is an FDA 510(k) clearance for the OXIMETER, CO-, IL MODEL 282. This device is classified as a Whole Blood Hemoglobin Determination (Class II - Special Controls, product code KHG).

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on July 26, 1976, 17 days after receiving the submission on July 9, 1976.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7500.

Submission Details

510(k) Number	K760208 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 09, 1976
Decision Date	July 26, 1976
Days to Decision	17 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—

Device Classification

Product Code	KHG — Whole Blood Hemoglobin Determination
Device Class	Class II - Special Controls
CFR Regulation	21 CFR 864.7500