The following data is part of a premarket notification filed by Zymed Medical Instrumentation with the FDA for Modification To Zymed Holter 2000.
| Device ID | K992197 |
| 510k Number | K992197 |
| Device Name: | MODIFICATION TO ZYMED HOLTER 2000 |
| Classification | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Applicant | ZYMED MEDICAL INSTRUMENTATION 20 NORTH AVIADOR ST. Camarillo, CA 93010 |
| Contact | Gretel Lumley |
| Correspondent | Gretel Lumley ZYMED MEDICAL INSTRUMENTATION 20 NORTH AVIADOR ST. Camarillo, CA 93010 |
| Product Code | MLO |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-30 |
| Decision Date | 1999-07-28 |
| Summary: | summary |