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 |