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 |
10841522129179 | K112962 | 000 |