510(k) K923730

MODEL 561 C-ARM PROCEDURES STRETCHER by Midmark Corp. — Product Code FPO

K923730 is an FDA 510(k) premarket notification submitted by Midmark Corp. for the device "MODEL 561 C-ARM PROCEDURES STRETCHER". The FDA issued a decision of Substantially Equivalent on February 9, 1994. The device falls under product code FPO (Stretcher, Wheeled), a Class II device regulated under 21 CFR 880.6910. Midmark Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1994
Date Received
July 27, 1992
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