Cleared Traditional

BLOOD GAS INCUBATOR #260650

K823766 · Boekel Industries, Inc. · Chemistry
Feb 1983
Decision
66d
Days
Class 1
Risk

About This 510(k) Submission

K823766 is an FDA 510(k) clearance for the BLOOD GAS INCUBATOR #260650, a Block, Heating (Class I — General Controls, product code JRG), submitted by Boekel Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 18, 1983, 66 days after receiving the submission on December 14, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K823766 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 1982
Decision Date February 18, 1983
Days to Decision 66 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JRG — Block, Heating
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2050