The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for Glenn Bed.
Device ID | K931581 |
510k Number | K931581 |
Device Name: | GLENN BED |
Classification | Bed, Ac-powered Adjustable Hospital |
Applicant | KINETIC CONCEPTS, INC. P.O. BOX 659508 San Antonio, TX 78265 -9508 |
Contact | William H Quirk |
Correspondent | William H Quirk KINETIC CONCEPTS, INC. P.O. BOX 659508 San Antonio, TX 78265 -9508 |
Product Code | FNL |
CFR Regulation Number | 880.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-30 |
Decision Date | 1993-10-21 |