The following data is part of a premarket notification filed by Medivision (u.s.a.), Inc. with the FDA for Medivision Igs System.
| Device ID | K003699 |
| 510k Number | K003699 |
| Device Name: | MEDIVISION IGS SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MEDIVISION (U.S.A.), INC. 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Sandra Williamson |
| Correspondent | Sandra Williamson MEDIVISION (U.S.A.), INC. 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-01 |
| Decision Date | 2001-02-27 |