The following data is part of a premarket notification filed by Janco Consulting Services with the FDA for Mc Acclaim Q6000 Bed.
Device ID | K951161 |
510k Number | K951161 |
Device Name: | MC ACCLAIM Q6000 BED |
Classification | Bed, Ac-powered Adjustable Hospital |
Applicant | JANCO CONSULTING SERVICES 6839 MONTEVIDEO ROAD MISSISSAUGA, ONTARIO L5n 1n7 Canada, CA L5n 1n7 |
Contact | Janet Shaw |
Correspondent | Janet Shaw JANCO CONSULTING SERVICES 6839 MONTEVIDEO ROAD MISSISSAUGA, ONTARIO L5n 1n7 Canada, CA L5n 1n7 |
Product Code | FNL |
CFR Regulation Number | 880.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-14 |
Decision Date | 1995-05-09 |