Cleared Traditional

SEVOFLURANE VAPORIZER ADAPTOR

K110608 · Piramal Critcal Care, Inc (Formerly Minrad, Inc) · Anesthesiology

Jul 2011

Decision

139d

Days

Class 2

Risk

About This 510(k) Submission

K110608 is an FDA 510(k) clearance for the SEVOFLURANE VAPORIZER ADAPTOR, a Vaporizer, Anesthesia, Non-heated (Class II — Special Controls, product code CAD), submitted by Piramal Critcal Care, Inc (Formerly Minrad, Inc) (Orchard Park, US). The FDA issued a Cleared decision on July 20, 2011, 139 days after receiving the submission on March 3, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5880.

Submission Details

510(k) Number	K110608 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 03, 2011
Decision Date	July 20, 2011
Days to Decision	139 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF