Cleared Traditional

HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX

K893133 · Mennen Medical, Inc. · Anesthesiology

Jul 1989

Decision

80d

Days

Class 2

Risk

About This 510(k) Submission

K893133 is an FDA 510(k) clearance for the HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX, a Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia (Class II — Special Controls, product code KLK), submitted by Mennen Medical, Inc. (Clarence, US). The FDA issued a Cleared decision on July 14, 1989, 80 days after receiving the submission on April 25, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2500.

Submission Details

510(k) Number	K893133 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 25, 1989
Decision Date	July 14, 1989
Days to Decision	80 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—

Device Classification

Product Code	KLK — Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.2500