The following data is part of a premarket notification filed by Progressive Medical Technology, Inc. with the FDA for B.a.s.e. Bellows Air Support Equipment.
Device ID | K915671 |
510k Number | K915671 |
Device Name: | B.A.S.E. BELLOWS AIR SUPPORT EQUIPMENT |
Classification | Bed, Flotation Therapy, 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 | IOQ |
CFR Regulation Number | 890.5170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-11-25 |
Decision Date | 1992-01-13 |