The following data is part of a premarket notification filed by Monteris Medical with the FDA for Atama System.
| Device ID | K132444 |
| 510k Number | K132444 |
| Device Name: | ATAMA SYSTEM |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MONTERIS MEDICAL 1193 SHERMAN STREET Alameda, CA 94501 |
| Contact | Brian J Edwards |
| Correspondent | Brian J Edwards MONTERIS MEDICAL 1193 SHERMAN STREET Alameda, CA 94501 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-06 |
| Decision Date | 2014-01-27 |
| Summary: | summary |