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 |