510(k) K772262

TRAPEZE BAR KNOCKED DOWN by Med Fusion Systems, Inc. — Product Code FNJ

K772262 is an FDA 510(k) premarket notification submitted by Med Fusion Systems, Inc. for the device "TRAPEZE BAR KNOCKED DOWN". The FDA issued a decision of Substantially Equivalent on January 26, 1978. The device falls under product code FNJ (Bed, Manual), a Class I device regulated under 21 CFR 880.5120. Med Fusion Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1978
Date Received
December 9, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Manual
Device Class
Class I
Regulation Number
880.5120
Review Panel
HO
Submission Type