The following data is part of a premarket notification filed by Radionics Software Applications, Inc. with the FDA for Stereoplan.
| Device ID | K946252 |
| 510k Number | K946252 |
| Device Name: | STEREOPLAN |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | RADIONICS SOFTWARE APPLICATIONS, INC. P.O. BOX 358 22 TERRY AVENUE Burlington, MA 01803 -0658 |
| Contact | Linda Jalbert |
| Correspondent | Linda Jalbert RADIONICS SOFTWARE APPLICATIONS, INC. P.O. BOX 358 22 TERRY AVENUE Burlington, MA 01803 -0658 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-23 |
| Decision Date | 1995-03-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() STEREOPLAN 74459330 1863598 Dead/Cancelled |
SHERWOOD SERVICES AG 1993-11-17 |