The following data is part of a premarket notification filed by Zymed Medical Instrumentation with the FDA for Multitrak-plus.
| Device ID | K930894 |
| 510k Number | K930894 |
| Device Name: | MULTITRAK-PLUS |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | ZYMED MEDICAL INSTRUMENTATION 20 NORTH AVIADOR ST. Camarillo, CA 93010 |
| Contact | Hosmel Galan |
| Correspondent | Hosmel Galan ZYMED MEDICAL INSTRUMENTATION 20 NORTH AVIADOR ST. Camarillo, CA 93010 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-22 |
| Decision Date | 1993-11-01 |