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 |
10841522122002 | K121480 | 000 |
10841522123825 | K121480 | 000 |
10841522123818 | K121480 | 000 |
10841522109676 | K121480 | 000 |
10841522101526 | K121480 | 000 |
10841522101472 | K121480 | 000 |
10841522101403 | K121480 | 000 |
10841522101335 | K121480 | 000 |
10841522101267 | K121480 | 000 |
10841522122019 | K121480 | 000 |
10841522122033 | K121480 | 000 |
10841522122064 | K121480 | 000 |
10841522107917 | K121480 | 000 |
10841522107900 | K121480 | 000 |
10841522107894 | K121480 | 000 |
10841522107887 | K121480 | 000 |
10841522107870 | K121480 | 000 |
10841522107863 | K121480 | 000 |
10841522107856 | K121480 | 000 |
10841522107849 | K121480 | 000 |
10841522122088 | K121480 | 000 |
10841522100581 | K121480 | 000 |