The following data is part of a premarket notification filed by Spacelabs Healthcare with the FDA for Xhibit Central Station, Model 96102.
| Device ID | K122146 |
| 510k Number | K122146 |
| Device Name: | XHIBIT CENTRAL STATION, MODEL 96102 |
| 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 | 2012-07-19 |
| Decision Date | 2013-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841522100345 | K122146 | 000 |
| 10841522127069 | K122146 | 000 |
| 10841522100536 | K122146 | 000 |
| 10841522122996 | K122146 | 000 |
| 10841522107832 | K122146 | 000 |
| 10841522107160 | K122146 | 000 |