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510(k) K051861

THE SAVION INDUSTRIES MEDI-CRUISER MODEL MS777 by Savion Industries, Ltd. — Product Code INK

K051861 is an FDA 510(k) premarket notification submitted by Savion Industries, Ltd. for the device "THE SAVION INDUSTRIES MEDI-CRUISER MODEL MS777". The FDA issued a decision of Substantially Equivalent on September 28, 2005. The device falls under product code INK (Stretcher, Wheeled, Powered), a Class II device regulated under 21 CFR 890.3690.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2005
Date Received
July 7, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stretcher, Wheeled, Powered
Device Class
Class II
Regulation Number
890.3690
Review Panel
PM
Submission Type

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FDA data resources