FDA Registration
BioMeridian operates under Food and Drug Administration 510(K) number K993824 for Meridian Stress Assessment. The intended use of BioMeridian devices is for the measurement of Galvanic Skin Response. BioMeridian is a registered establishment of the Food and Drug Administration. Registration number 1723429.
Registration Summary
| Device Classification Name | Device, Galvanic Skin Response Measurement |
| Regulation Number | 882.1540 |
| 510(K) Numbers |
K993824 K053004 |
| Device Name | MSAS Professional BioMeridian, Int. |
| Applicant |
2440 So. 1070 W. Suite A Salt Lake City, UT 84119 |
| Contact |
Frank Laughlin - Technical Support Manager - 801-208-8332 Russ Forsyth - Director of Quality Assurance - 801-208-6965 |
| Product Code | GZO |
| Date Received | 11/12/1999 |
| Decision Date | 01/20/2000 |
| Decision | Substantially Equivalent (SE) |
| Classification Advisory Committee | Neurology |
| Review Advisory Committee | Neurology |
| Statement/Summary/Purged Status | Summary/ Purged 510 (K) |
| Type | Special |
| Reviewed By Third Party | No |
| Expedited Review | No |