Cleared Traditional

MERCURY CPAP

K090710 · Mercury Medical · Anesthesiology
Aug 2009
Decision
155d
Days
Class 2
Risk

About This 510(k) Submission

K090710 is an FDA 510(k) clearance for the MERCURY CPAP, a Attachment, Breathing, Positive End Expiratory Pressure (Class II — Special Controls, product code BYE), submitted by Mercury Medical (Bonita Springs, US). The FDA issued a Cleared decision on August 20, 2009, 155 days after receiving the submission on March 18, 2009. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5965.

Submission Details

510(k) Number K090710 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2009
Decision Date August 20, 2009
Days to Decision 155 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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