The following data is part of a premarket notification filed by Biomeridian, Int. with the FDA for Msas-vantage.
| Device ID | K053004 |
| 510k Number | K053004 |
| Device Name: | MSAS-VANTAGE |
| Classification | Device, Galvanic Skin Response Measurement |
| Applicant | BIOMERIDIAN, INT. 12411 SOUTH 265 WEST, SUITE F Draper, UT 84020 -8671 |
| Contact | Gene Swift |
| Correspondent | Gene Swift BIOMERIDIAN, INT. 12411 SOUTH 265 WEST, SUITE F Draper, UT 84020 -8671 |
| Product Code | GZO |
| CFR Regulation Number | 882.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-26 |
| Decision Date | 2006-01-13 |
| Summary: | summary |