The following data is part of a premarket notification filed by Bomdal Medical Equipment, Inc. with the FDA for Bomdal Standard Lift.
| Device ID | K862147 |
| 510k Number | K862147 |
| Device Name: | BOMDAL STANDARD LIFT |
| Classification | Lift, Patient, Ac-powered |
| Applicant | BOMDAL MEDICAL EQUIPMENT, INC. 51 VALECREST DR. Islington, Ontario, CA M9a 4p5 |
| Contact | Angelo Bonetta |
| Correspondent | Angelo Bonetta BOMDAL MEDICAL EQUIPMENT, INC. 51 VALECREST DR. Islington, Ontario, CA M9a 4p5 |
| Product Code | FNG |
| CFR Regulation Number | 880.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-04 |
| Decision Date | 1986-07-15 |