The following data is part of a premarket notification filed by Medtest Systems, Inc. with the FDA for Medisensor 2001.
| Device ID | K903564 |
| 510k Number | K903564 |
| Device Name: | MEDISENSOR 2001 |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | MEDTEST SYSTEMS, INC. 335 PAINT BRANCH DR. College Park, MD 20742 |
| Contact | Vino Guruswamy |
| Correspondent | Vino Guruswamy MEDTEST SYSTEMS, INC. 335 PAINT BRANCH DR. College Park, MD 20742 |
| Product Code | JGS |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-07 |
| Decision Date | 1991-09-30 |