The following data is part of a premarket notification filed by Draeger Medical Systems, Inc. with the FDA for Infinity Telesmart Telemetry System.
| Device ID | K061379 |
| 510k Number | K061379 |
| Device Name: | INFINITY TELESMART TELEMETRY SYSTEM |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Draeger Medical Systems, Inc. 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Contact | Thomas M Mcintosh |
| Correspondent | Thomas M Mcintosh Draeger Medical Systems, Inc. 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-17 |
| Decision Date | 2007-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049098050449 | K061379 | 000 |
| 04049098007078 | K061379 | 000 |
| 04049098004190 | K061379 | 000 |