The following data is part of a premarket notification filed by Zymed Medical Instrumentation with the FDA for Zybit.
| Device ID | K002004 |
| 510k Number | K002004 |
| Device Name: | ZYBIT |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | ZYMED MEDICAL INSTRUMENTATION 1201 B NORTH RICE AVE. Oxnard, CA 93030 |
| Contact | Gretel Lumley |
| Correspondent | Gretel Lumley ZYMED MEDICAL INSTRUMENTATION 1201 B NORTH RICE AVE. Oxnard, CA 93030 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-03 |
| Decision Date | 2000-09-21 |