The following data is part of a premarket notification filed by Progressive Medical Technology, Inc. with the FDA for Oscillair 3000 Low Air Loss Kinetic Therapy Bed.
Device ID | K923710 |
510k Number | K923710 |
Device Name: | OSCILLAIR 3000 LOW AIR LOSS KINETIC THERAPY BED |
Classification | Bed, Patient Rotation, Powered |
Applicant | PROGRESSIVE MEDICAL TECHNOLOGY, INC. 815 TERMINAL RD. Lansing, MI 48906 |
Contact | Van Dyke |
Correspondent | Van Dyke PROGRESSIVE MEDICAL TECHNOLOGY, INC. 815 TERMINAL RD. Lansing, MI 48906 |
Product Code | IKZ |
CFR Regulation Number | 890.5225 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-27 |
Decision Date | 1993-03-22 |