The following data is part of a premarket notification filed by I.s.g. Technologies, Inc. with the FDA for Isg Family Of Viewing Wands.
| Device ID | K970865 |
| 510k Number | K970865 |
| Device Name: | ISG FAMILY OF VIEWING WANDS |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | I.S.G. TECHNOLOGIES, INC. 6509 AIRPORT ROAD Mississauga, Ontario, CA L4v 1s7 |
| Contact | Charles Hall |
| Correspondent | Charles Hall I.S.G. TECHNOLOGIES, INC. 6509 AIRPORT ROAD Mississauga, Ontario, CA L4v 1s7 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-10 |
| Decision Date | 1997-06-04 |
| Summary: | summary |