510(k) K852174

MERIVAARA OBSTETRIC CHAIR/BED MODEL 358 by Daun International, Inc. — Product Code KNC

K852174 is an FDA 510(k) premarket notification submitted by Daun International, Inc. for the device "MERIVAARA OBSTETRIC CHAIR/BED MODEL 358". The FDA issued a decision of Substantially Equivalent on September 6, 1985. The device falls under product code KNC (Table, Obstetric (And Accessories)), a Class II device regulated under 21 CFR 884.4900. Daun International, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1985
Date Received
May 20, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Obstetric (And Accessories)
Device Class
Class II
Regulation Number
884.4900
Review Panel
OB
Submission Type