The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for Turbo.
Device ID | K912854 |
510k Number | K912854 |
Device Name: | TURBO |
Classification | Bed, Flotation Therapy, Powered |
Applicant | KINETIC CONCEPTS, INC. P.O. BOX 8588 San Antonio, TX 78208 |
Contact | William H Quirk |
Correspondent | William H Quirk KINETIC CONCEPTS, INC. P.O. BOX 8588 San Antonio, TX 78208 |
Product Code | IOQ |
CFR Regulation Number | 890.5170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-06-28 |
Decision Date | 1991-12-20 |