The following data is part of a premarket notification filed by Ch Administration, Inc. with the FDA for Comfort Care Low Air Loss Therapy Bed.
Device ID | K926402 |
510k Number | K926402 |
Device Name: | COMFORT CARE LOW AIR LOSS THERAPY BED |
Classification | Bed, Air Fluidized |
Applicant | CH ADMINISTRATION, INC. P.O. BOX 29923 Dallas, TX 75229 |
Contact | John A Carbona |
Correspondent | John A Carbona CH ADMINISTRATION, INC. P.O. BOX 29923 Dallas, TX 75229 |
Product Code | INX |
CFR Regulation Number | 890.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-21 |
Decision Date | 1993-03-24 |