510(k) K940245

EVACU-SLED by Evacu Technologies, Inc. — Product Code FPP

K940245 is an FDA 510(k) premarket notification submitted by Evacu Technologies, Inc. for the device "EVACU-SLED". The FDA issued a decision of Substantially Equivalent on February 28, 1994. The device falls under product code FPP (Stretcher, Hand-Carried), a Class I device regulated under 21 CFR 880.6900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1994
Date Received
January 19, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stretcher, Hand-Carried
Device Class
Class I
Regulation Number
880.6900
Review Panel
HO
Submission Type