The following data is part of a premarket notification filed by Andronic Devices, Ltd. with the FDA for Arthrobot(tm) Wrist Holder Accessory.
| Device ID | K911522 |
| 510k Number | K911522 |
| Device Name: | ARTHROBOT(TM) WRIST HOLDER ACCESSORY |
| Classification | Table, Surgical With Orthopedic Accessories, Ac-powered |
| Applicant | ANDRONIC DEVICES, LTD. 13120 VANIER PL SUITE 140 Richmond,b.c. V6v-2j2, CA |
| Contact | Michael Chan |
| Correspondent | Michael Chan ANDRONIC DEVICES, LTD. 13120 VANIER PL SUITE 140 Richmond,b.c. V6v-2j2, CA |
| Product Code | JEA |
| CFR Regulation Number | 878.4960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-04 |
| Decision Date | 1991-04-29 |