The following data is part of a premarket notification filed by Integrated Medical Equipment Co. with the FDA for Low Air Loss Bed.
Device ID | K871705 |
510k Number | K871705 |
Device Name: | LOW AIR LOSS BED |
Classification | Mattress, Air Flotation, Alternating Pressure |
Applicant | INTEGRATED MEDICAL EQUIPMENT CO. 104 EAST STATE ST. Ridgeland, MS 39157 |
Contact | Thad Hawkins |
Correspondent | Thad Hawkins INTEGRATED MEDICAL EQUIPMENT CO. 104 EAST STATE ST. Ridgeland, MS 39157 |
Product Code | FNM |
CFR Regulation Number | 880.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-01 |
Decision Date | 1987-10-09 |