The following data is part of a premarket notification filed by Faro Medical Technologies, Inc. with the FDA for Free Arm(tm).
| Device ID | K884928 |
| 510k Number | K884928 |
| Device Name: | FREE ARM(TM) |
| Classification | Operating Room Accessories Table Tray |
| Applicant | FARO MEDICAL TECHNOLOGIES, INC. 2875 SABOURIN ST QUEBEC Montreal H4s 1m9, CA |
| Contact | Fraser, Phd |
| Correspondent | Fraser, Phd FARO MEDICAL TECHNOLOGIES, INC. 2875 SABOURIN ST QUEBEC Montreal H4s 1m9, CA |
| Product Code | FWZ |
| CFR Regulation Number | 878.4950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-28 |
| Decision Date | 1988-12-15 |