The following data is part of a premarket notification filed by Andronic Devices, Ltd. with the FDA for Arthrobot(tm) Lower Limb Positioner.
| Device ID | K880227 |
| 510k Number | K880227 |
| Device Name: | ARTHROBOT(TM) LOWER LIMB POSITIONER |
| Classification | Table, Operating-room, Ac-powered |
| Applicant | ANDRONIC DEVICES, LTD. BOX 58382 VANCOUVER Canada, CA V6p 6e4 |
| Contact | Macneil P.eng |
| Correspondent | Macneil P.eng ANDRONIC DEVICES, LTD. BOX 58382 VANCOUVER Canada, CA V6p 6e4 |
| Product Code | FQO |
| CFR Regulation Number | 878.4960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-20 |
| Decision Date | 1988-02-18 |