Cleared Traditional

K822564 - WATER BATH
(FDA 510(k) Clearance)

Sep 1982
Decision
21d
Days
Class 1
Risk

K822564 is an FDA 510(k) clearance for the WATER BATH. This device is classified as a Bath, Incubators/water, All (Class I - General Controls, product code JTQ).

Submitted by Boekel Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1982, 21 days after receiving the submission on August 24, 1982.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2540.

Submission Details

510(k) Number K822564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1982
Decision Date September 14, 1982
Days to Decision 21 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code JTQ — Bath, Incubators/water, All
Device Class Class I - General Controls
CFR Regulation 21 CFR 866.2540

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