K970865 is an FDA 510(k) clearance for the ISG FAMILY OF VIEWING WANDS. This device is classified as a Neurological Stereotaxic Instrument (Class II - Special Controls, product code HAW).
Submitted by I.S.G. Technologies, Inc. (Mississauga Ontario, CA). The FDA issued a Cleared decision on June 4, 1997, 86 days after receiving the submission on March 10, 1997.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4560.
| 510(k) Number | K970865 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 1997 |
| Decision Date | June 04, 1997 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HAW — Neurological Stereotaxic Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |