The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Reflective Sphere Standard Probe And Reflective Sphere Dynamic Reference Frame.
| Device ID | K983603 |
| 510k Number | K983603 |
| Device Name: | REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAME |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Contact | Kevin O'connell |
| Correspondent | Kevin 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 | 1998-10-14 |
| Decision Date | 1998-11-10 |
| Summary: | summary |