The following data is part of a premarket notification filed by Daun International, Inc. with the FDA for Merivaara Hospital Bed.
Device ID | K851552 |
510k Number | K851552 |
Device Name: | MERIVAARA HOSPITAL BED |
Classification | Bed, Manual |
Applicant | DAUN INTERNATIONAL, INC. 431 SOUTH DEARBORN ST., SU 705 Chicago, IL 60605 |
Contact | Glenn Z Hering |
Correspondent | Glenn Z Hering DAUN INTERNATIONAL, INC. 431 SOUTH DEARBORN ST., SU 705 Chicago, IL 60605 |
Product Code | FNJ |
CFR Regulation Number | 880.5120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-16 |
Decision Date | 1985-05-08 |