The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Non-invasive Dynamic Reference Frame (drf) For Optical Tracking System, Model Ots.
| Device ID | K984245 |
| 510k Number | K984245 |
| Device Name: | NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Contact | Kevin J O'connell |
| Correspondent | Kevin J O'connell RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-27 |
| Decision Date | 1998-12-18 |
| Summary: | summary |