510(k) K943262

FUTURA JUNIOR 300/310 by Merivaara Instrumentarium Corp. — Product Code FPO

K943262 is an FDA 510(k) premarket notification submitted by Merivaara Instrumentarium Corp. for the device "FUTURA JUNIOR 300/310". The FDA issued a decision of Substantially Equivalent on September 29, 1994. The device falls under product code FPO (Stretcher, Wheeled), a Class II device regulated under 21 CFR 880.6910. Merivaara Instrumentarium Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1994
Date Received
July 7, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stretcher, Wheeled
Device Class
Class II
Regulation Number
880.6910
Review Panel
HO
Submission Type