K090240 is an FDA 510(k) clearance for the MONTERIS MEDICAL UFO. This device is classified as a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW).
Submitted by Monteris Medical, (Alameda, US). The FDA issued a Cleared decision on August 6, 2009, 185 days after receiving the submission on February 2, 2009.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4560.
| 510(k) Number | K090240 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2009 |
| Decision Date | August 06, 2009 |
| Days to Decision | 185 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 |