The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for Kudo (powered Rotation Bed).
| Device ID | K905390 |
| 510k Number | K905390 |
| Device Name: | KUDO (POWERED ROTATION BED) |
| Classification | Bed, Patient Rotation, Powered |
| Applicant | KINETIC CONCEPTS, INC. P.O. BOX 8588 San Antonio, TX 78208 |
| Contact | Wehrmeyer, Jr |
| Correspondent | Wehrmeyer, Jr KINETIC CONCEPTS, INC. P.O. BOX 8588 San Antonio, TX 78208 |
| Product Code | IKZ |
| CFR Regulation Number | 890.5225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-30 |
| Decision Date | 1991-01-08 |