The following data is part of a premarket notification filed by Medical Systems Corp. with the FDA for Cardiomatic Model Msc-2001.
| Device ID | K904353 |
| 510k Number | K904353 |
| Device Name: | CARDIOMATIC MODEL MSC-2001 |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | MEDICAL SYSTEMS CORP. ONE PLAZA RD. Greenvale, NY 11548 -9801 |
| Contact | Mardin Varela |
| Correspondent | Mardin Varela MEDICAL SYSTEMS CORP. ONE PLAZA RD. Greenvale, NY 11548 -9801 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-24 |
| Decision Date | 1990-12-20 |