The following data is part of a premarket notification filed by Spacelabs Healthcare with the FDA for Elance Vital Signs Monitor, Central Monitor Software.
Device ID | K150329 |
510k Number | K150329 |
Device Name: | Elance Vital Signs Monitor, Central Monitor Software |
Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
Applicant | SPACELABS HEALTHCARE 35301 SE CENTER STREET Snoqualmie, WA 98065 |
Contact | Al Van Houdt |
Correspondent | Thomas Kroenke Speed To Market, Inc. PO Box 3018 Nederland, CO 80466 |
Product Code | MHX |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-02-10 |
Decision Date | 2015-11-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10841522128479 | K150329 | 000 |
10841522128462 | K150329 | 000 |
10841522128455 | K150329 | 000 |