510(k) K121929
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