510(k) K905381

MANHANDLER by Lifeport, Inc. — Product Code FPP

K905381 is an FDA 510(k) premarket notification submitted by Lifeport, Inc. for the device "MANHANDLER". The FDA issued a decision of Substantially Equivalent on March 13, 1991. 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
March 13, 1991
Date Received
November 29, 1990
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