The following data is part of a premarket notification filed by Lexicor Medical Technology, Inc. with the FDA for Mrs-2d.
| Device ID | K961645 |
| 510k Number | K961645 |
| Device Name: | MRS-2D |
| Classification | Device, Biofeedback |
| Applicant | LEXICOR MEDICAL TECHNOLOGY, INC. 5589 ARAPAHOE AVE., #206 Boulder, CO 80303 |
| Contact | Michael M Shupe |
| Correspondent | Michael M Shupe LEXICOR MEDICAL TECHNOLOGY, INC. 5589 ARAPAHOE AVE., #206 Boulder, CO 80303 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-29 |
| Decision Date | 1996-10-31 |
| Summary: | summary |