The following data is part of a premarket notification filed by Spacelabs Medical Inc. with the FDA for Spacelabs Healthcare Xprezzon Beside Monitor(9913930).
| Device ID | K112962 |
| 510k Number | K112962 |
| Device Name: | SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930) |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | SPACELABS MEDICAL INC. 5150 220TH AVE SE Issaquah, WA 98029 |
| Contact | Davvid J Geraghty |
| Correspondent | Davvid J Geraghty SPACELABS MEDICAL INC. 5150 220TH AVE SE Issaquah, WA 98029 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-05 |
| Decision Date | 2011-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841522104565 | K112962 | 000 |
| 10841522104534 | K112962 | 000 |
| 10841522100093 | K112962 | 000 |
| 10841522100109 | K112962 | 000 |
| 10841522100079 | K112962 | 000 |
| 10841522126024 | K112962 | 000 |
| 10841522131035 | K112962 | 000 |