510(k) K121929

ZEPHYR 'X-SERIES PATIENT TRANSFER SLED by Diacor, Inc. — Product Code FRZ

K121929 is an FDA 510(k) premarket notification submitted by Diacor, Inc. for the device "ZEPHYR 'X-SERIES PATIENT TRANSFER SLED". The FDA issued a decision of Substantially Equivalent on January 17, 2013. The device falls under product code FRZ (Device, Patient Transfer, Powered), a Class II device regulated under 21 CFR 880.6775. Diacor, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2013
Date Received
July 2, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Patient Transfer, Powered
Device Class
Class II
Regulation Number
880.6775
Review Panel
HO
Submission Type