Cleared Traditional

K925263 - MERIDIAN MEDICAL SYSTEMS CONNECTORS & AIRWAY EXT (FDA 510(k) Clearance)

Feb 1993
Decision
106d
Days
Class 1
Risk

K925263 is an FDA 510(k) clearance for the MERIDIAN MEDICAL SYSTEMS CONNECTORS & AIRWAY EXT. This device is classified as a Connector, Airway (extension) (Class I - General Controls, product code BZA).

Submitted by Merit Medical Systems, Inc. (Indianapolis, US). The FDA issued a Cleared decision on February 2, 1993, 106 days after receiving the submission on October 19, 1992.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5810.

Submission Details

510(k) Number K925263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1992
Decision Date February 02, 1993
Days to Decision 106 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BZA — Connector, Airway (extension)
Device Class Class I - General Controls
CFR Regulation 21 CFR 868.5810