The following data is part of a premarket notification filed by Monteris Medical with the FDA for Monteris Medical Ufo.
| Device ID | K090240 |
| 510k Number | K090240 |
| Device Name: | MONTERIS MEDICAL UFO |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MONTERIS MEDICAL 1193 SHERMAN STREET Alameda, CA 94501 |
| Contact | Craig Coombs |
| Correspondent | Craig Coombs MONTERIS MEDICAL 1193 SHERMAN STREET Alameda, CA 94501 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-02 |
| Decision Date | 2009-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816589020182 | K090240 | 000 |