Cleared Traditional

VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)

K964978 · Quinton, Inc. · Anesthesiology
May 1997
Decision
160d
Days
Class 2
Risk

About This 510(k) Submission

K964978 is an FDA 510(k) clearance for the VITAL STATISTICS SYSTEM (O-CATH ACCESSORY), a Oximeter (Class II — Special Controls, product code DQA), submitted by Quinton, Inc. (Bothell, US). The FDA issued a Cleared decision on May 21, 1997, 160 days after receiving the submission on December 12, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K964978 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 1996
Decision Date May 21, 1997
Days to Decision 160 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code DQA — Oximeter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700

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