510(k) K972528

DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759) by Dyna Corp. — Product Code FPO

K972528 is an FDA 510(k) premarket notification submitted by Dyna Corp. for the device "DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759)". The FDA issued a decision of Substantially Equivalent on July 28, 1997. The device falls under product code FPO (Stretcher, Wheeled), a Class II device regulated under 21 CFR 880.6910. Dyna Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1997
Date Received
July 7, 1997
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