The following data is part of a premarket notification filed by Apollo Fluid Dynamics with the FDA for Apollo Air Fluidized Bed.
Device ID | K842987 |
510k Number | K842987 |
Device Name: | APOLLO AIR FLUIDIZED BED |
Classification | Bed, Air Fluidized |
Applicant | APOLLO FLUID DYNAMICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | INX |
CFR Regulation Number | 890.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-07-30 |
Decision Date | 1984-08-02 |