The following data is part of a premarket notification filed by Telzuit Technologies, Inc. with the FDA for Telzuit Cardiac Monitoring System.
| Device ID | K031229 |
| 510k Number | K031229 |
| Device Name: | TELZUIT CARDIAC MONITORING SYSTEM |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | TELZUIT TECHNOLOGIES, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia J.m. Nolet |
| Correspondent | Cynthia J.m. Nolet TELZUIT TECHNOLOGIES, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-18 |
| Decision Date | 2003-07-09 |
| Summary: | summary |