The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for Egerton Turning & Tilting Bed.
Device ID | K834563 |
510k Number | K834563 |
Device Name: | EGERTON TURNING & TILTING BED |
Classification | Bed, Patient Rotation, Powered |
Applicant | KINETIC CONCEPTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IKZ |
CFR Regulation Number | 890.5225 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-12-28 |
Decision Date | 1984-01-30 |