510(k) K852173

MERIVAARA CRIB TROLLEY-MODEL 381 by Daun International, Inc. — Product Code FMS

K852173 is an FDA 510(k) premarket notification submitted by Daun International, Inc. for the device "MERIVAARA CRIB TROLLEY-MODEL 381". The FDA issued a decision of Substantially Equivalent on June 17, 1985. The device falls under product code FMS (Bed, Pediatric Open Hospital), a Class II device regulated under 21 CFR 880.5140. Daun International, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1985
Date Received
May 20, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Pediatric Open Hospital
Device Class
Class II
Regulation Number
880.5140
Review Panel
HO
Submission Type