510(k) K852174
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