Cleared Traditional

SENTRYSUITE PRODUCT LINE

K122699 · Carefusion Germany 234 GmbH · Anesthesiology
Nov 2012
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K122699 is an FDA 510(k) clearance for the SENTRYSUITE PRODUCT LINE, a Calculator, Predicted Values, Pulmonary Function (Class II — Special Controls, product code BTY), submitted by Carefusion Germany 234 GmbH (Hoechberg, DE). The FDA issued a Cleared decision on November 19, 2012, 76 days after receiving the submission on September 4, 2012. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number K122699 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 2012
Decision Date November 19, 2012
Days to Decision 76 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTY — Calculator, Predicted Values, Pulmonary Function
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1890

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