The following data is part of a premarket notification filed by Spacelabs Healthcare with the FDA for Spacelabs Healthcare Telemetry Receiver.
| Device ID | K141156 |
| 510k Number | K141156 |
| Device Name: | SPACELABS HEALTHCARE TELEMETRY RECEIVER |
| 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 |
| Subsequent Product Code | DSI |
| Subsequent Product Code | MLD |
| Subsequent Product Code | MSX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-05 |
| Decision Date | 2014-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841522124754 | K141156 | 000 |
| 10841522120213 | K141156 | 000 |
| 10841522120206 | K141156 | 000 |
| 10841522120190 | K141156 | 000 |
| 10841522107177 | K141156 | 000 |
| 10841522106514 | K141156 | 000 |
| 10841522102875 | K141156 | 000 |
| 10841522102868 | K141156 | 000 |
| 10841522102738 | K141156 | 000 |
| 10841522102714 | K141156 | 000 |
| 10841522102707 | K141156 | 000 |
| 10841522102691 | K141156 | 000 |
| 10841522120220 | K141156 | 000 |
| 10841522120237 | K141156 | 000 |
| 10841522102721 | K141156 | 000 |
| 10841522102882 | K141156 | 000 |
| 10841522127052 | K141156 | 000 |
| 10841522127045 | K141156 | 000 |
| 10841522127038 | K141156 | 000 |
| 10841522127021 | K141156 | 000 |
| 10841522120282 | K141156 | 000 |
| 10841522120275 | K141156 | 000 |
| 10841522120268 | K141156 | 000 |
| 10841522120251 | K141156 | 000 |
| 10841522120244 | K141156 | 000 |
| 10841522100246 | K141156 | 000 |