The following data is part of a premarket notification filed by Burke Mobility Products with the FDA for Burke Bariatric Treatment System Ii.
| Device ID | K925576 |
| 510k Number | K925576 |
| Device Name: | BURKE BARIATRIC TREATMENT SYSTEM II |
| Classification | Bed, Ac-powered Adjustable Hospital |
| Applicant | BURKE MOBILITY PRODUCTS P.O. BOX 1064 Mission, KS 66222 |
| Contact | Duwayne E Kramer |
| Correspondent | Duwayne E Kramer BURKE MOBILITY PRODUCTS P.O. BOX 1064 Mission, KS 66222 |
| Product Code | FNL |
| CFR Regulation Number | 880.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-03 |
| Decision Date | 1993-06-04 |