Cleared Traditional

K881371 - COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE
(FDA 510(k) Clearance)

K881371 · Cox Sterile Products, Inc. · General Hospital

Apr 1988

Decision

12d

Days

Class 2

Risk

K881371 is an FDA 510(k) clearance for the COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE. This device is classified as a Sterilizer, Dry Heat (Class II — Special Controls, product code KMH).

Submitted by Cox Sterile Products, Inc. (Dallas, US). The FDA issued a Cleared decision on April 13, 1988, 12 days after receiving the submission on April 1, 1988.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6870.

Submission Details

510(k) Number	K881371 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 01, 1988
Decision Date	April 13, 1988
Days to Decision	12 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—