K961834 is an FDA 510(k) clearance for the PHILIPS EASYGUIDE NEURO. This device is classified as a Neurological Stereotaxic Instrument (Class II - Special Controls, product code HAW).
Submitted by Philips Medical Systems, Inc. (Shelton, US). The FDA issued a Cleared decision on November 8, 1996, 179 days after receiving the submission on May 13, 1996.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4560.
| 510(k) Number | K961834 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 1996 |
| Decision Date | November 08, 1996 |
| Days to Decision | 179 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 |