The following data is part of a premarket notification filed by Zymed Medical Instrumentation with the FDA for Zymed Holter Scanner Model 2010.
| Device ID | K955015 |
| 510k Number | K955015 |
| Device Name: | ZYMED HOLTER SCANNER MODEL 2010 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | ZYMED MEDICAL INSTRUMENTATION 20 NORTH AVIADOR ST. Camarillo, CA 93010 |
| Contact | John Dudley Harris |
| Correspondent | John Dudley Harris ZYMED MEDICAL INSTRUMENTATION 20 NORTH AVIADOR ST. Camarillo, CA 93010 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-01 |
| Decision Date | 1996-03-18 |
| Summary: | summary |