The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Universal Instrument Registration (uir) Microscope Module I.
| Device ID | K981213 |
| 510k Number | K981213 |
| Device Name: | UNIVERSAL INSTRUMENT REGISTRATION (UIR) MICROSCOPE MODULE I |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Contact | Lisa M Benati |
| Correspondent | Lisa M Benati RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-02 |
| Decision Date | 1998-07-01 |
| Summary: | summary |