The following data is part of a premarket notification filed by Daun International, Inc. with the FDA for Merivaara Obstetric Chair/bed Model 358.
Device ID | K852174 |
510k Number | K852174 |
Device Name: | MERIVAARA OBSTETRIC CHAIR/BED MODEL 358 |
Classification | Table, Obstetric (and Accessories) |
Applicant | DAUN INTERNATIONAL, INC. 431 SOUTH DEARBORN ST., SU 705 Chicago, IL 60605 |
Contact | Bradford J Perino |
Correspondent | Bradford J Perino DAUN INTERNATIONAL, INC. 431 SOUTH DEARBORN ST., SU 705 Chicago, IL 60605 |
Product Code | KNC |
CFR Regulation Number | 884.4900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-20 |
Decision Date | 1985-09-06 |