The following data is part of a premarket notification filed by Portal, Inc. with the FDA for Portal Gravity System.
| Device ID | K052579 |
| 510k Number | K052579 |
| Device Name: | PORTAL GRAVITY SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PORTAL, INC. 1350 NORTH 200 WEST, #6 P.O. BOX 6141 Logan, UT 84341 |
| Contact | David Carter |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-09-20 |
| Decision Date | 2005-09-27 |