510(k) K945431

MODEL 792 CONVERGE, MODEL 793 VISION 2000 by Hausted, Inc. — Product Code FPO

K945431 is an FDA 510(k) premarket notification submitted by Hausted, Inc. for the device "MODEL 792 CONVERGE, MODEL 793 VISION 2000". The FDA issued a decision of Substantially Equivalent on January 25, 1995. The device falls under product code FPO (Stretcher, Wheeled), a Class II device regulated under 21 CFR 880.6910. Hausted, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1995
Date Received
August 15, 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