The following data is part of a premarket notification filed by Andronic Devices, Ltd. with the FDA for Arthrobot Bi-fold Drape.
| Device ID | K932253 |
| 510k Number | K932253 |
| Device Name: | ARTHROBOT BI-FOLD DRAPE |
| Classification | Drape, Surgical |
| Applicant | ANDRONIC DEVICES, LTD. 13120 VANIER PL SUITE 140 Richmond,b.c. V6v-2j2, CA |
| Contact | Robert Macneil |
| Correspondent | Robert Macneil ANDRONIC DEVICES, LTD. 13120 VANIER PL SUITE 140 Richmond,b.c. V6v-2j2, CA |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-10 |
| Decision Date | 1994-02-03 |