Cleared Traditional

ZEPHYR 'X-SERIES PATIENT TRANSFER SLED

K121929 · Diacor, Inc. · Radiology
Jan 2013
Decision
199d
Days
Class 2
Risk

About This 510(k) Submission

K121929 is an FDA 510(k) clearance for the ZEPHYR 'X-SERIES PATIENT TRANSFER SLED, a Device, Patient Transfer, Powered (Class II — Special Controls, product code FRZ), submitted by Diacor, Inc. (West Valley City, US). The FDA issued a Cleared decision on January 17, 2013, 199 days after receiving the submission on July 2, 2012. This device falls under the Radiology review panel. Regulated under 21 CFR 880.6775.

Submission Details

510(k) Number K121929 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2012
Decision Date January 17, 2013
Days to Decision 199 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code FRZ — Device, Patient Transfer, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6775