Cleared Traditional

NASAL CANNULA

K935533 · Puritas Health Care, Inc. · Anesthesiology
Feb 1994
Decision
79d
Days
Class 1
Risk

About This 510(k) Submission

K935533 is an FDA 510(k) clearance for the NASAL CANNULA, a Cannula, Nasal, Oxygen (Class I — General Controls, product code CAT), submitted by Puritas Health Care, Inc. (New Milford, US). The FDA issued a Cleared decision on February 3, 1994, 79 days after receiving the submission on November 16, 1993. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5340.

Submission Details

510(k) Number K935533 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 1993
Decision Date February 03, 1994
Days to Decision 79 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code CAT — Cannula, Nasal, Oxygen
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5340

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