Cleared Traditional

KENDALL SHERIDAN CPAP SYSTEM

K953511 · Kendall Healthcare Products Co. Div.Of Tyco Health · Anesthesiology
Oct 1995
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K953511 is an FDA 510(k) clearance for the KENDALL SHERIDAN CPAP SYSTEM, a Attachment, Breathing, Positive End Expiratory Pressure (Class II — Special Controls, product code BYE), submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on October 26, 1995, 92 days after receiving the submission on July 26, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5965.

Submission Details

510(k) Number K953511 FDA.gov
FDA Decision Cleared SESK
Date Received July 26, 1995
Decision Date October 26, 1995
Days to Decision 92 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BYE — Attachment, Breathing, Positive End Expiratory Pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5965

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