The following data is part of a premarket notification filed by Spacelabs Healthcare with the FDA for Ariatele Telemetry Transmitter (96281).
| Device ID | K121480 |
| 510k Number | K121480 |
| Device Name: | ARIATELE TELEMETRY TRANSMITTER (96281) |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | SPACELABS HEALTHCARE P.O. BOX 3018 Nederland, CO 80466 |
| Contact | Thomas Kroenke |
| Correspondent | Thomas Kroenke SPACELABS HEALTHCARE P.O. BOX 3018 Nederland, CO 80466 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-18 |
| Decision Date | 2012-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841522100352 | K121480 | 000 |
| 10841522123825 | K121480 | 000 |
| 10841522122002 | K121480 | 000 |
| 10841522122019 | K121480 | 000 |
| 10841522122033 | K121480 | 000 |
| 10841522122064 | K121480 | 000 |
| 10841522122088 | K121480 | 000 |
| 10841522107849 | K121480 | 000 |
| 10841522107856 | K121480 | 000 |
| 10841522107863 | K121480 | 000 |
| 10841522107870 | K121480 | 000 |
| 10841522107887 | K121480 | 000 |
| 10841522107894 | K121480 | 000 |
| 10841522107900 | K121480 | 000 |
| 10841522107917 | K121480 | 000 |
| 10841522123818 | K121480 | 000 |