The following data is part of a premarket notification filed by Spacelabs Medical, Inc. with the FDA for Spacelabs Healthcare Qube Compact Monitor (91390.
Device ID | K120616 |
510k Number | K120616 |
Device Name: | SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390 |
Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
Applicant | SPACELABS MEDICAL, INC. PO BOX 3018 Nederland, CO 80466 |
Contact | Thomas Kroenke |
Correspondent | Thomas Kroenke SPACELABS MEDICAL, INC. PO BOX 3018 Nederland, CO 80466 |
Product Code | MHX |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-02-29 |
Decision Date | 2012-03-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10841522127328 | K120616 | 000 |
10841522127311 | K120616 | 000 |
10841522127304 | K120616 | 000 |
10841522100239 | K120616 | 000 |
10841522100550 | K120616 | 000 |
10841522102554 | K120616 | 000 |
10841522100574 | K120616 | 000 |