510(k) K103536

IBED WIRELESS WITH IBED AWARENESS by Stryker Corporation — Product Code FNL

K103536 is an FDA 510(k) premarket notification submitted by Stryker Corporation for the device "IBED WIRELESS WITH IBED AWARENESS". The FDA issued a decision of Substantially Equivalent on December 16, 2010. The device falls under product code FNL (Bed, Ac-Powered Adjustable Hospital), a Class II device regulated under 21 CFR 880.5100. Stryker Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2010
Date Received
December 1, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Bed, Ac-Powered Adjustable Hospital
Device Class
Class II
Regulation Number
880.5100
Review Panel
HO
Submission Type