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 |
| 10841522131462 | K120616 | 000 |
| 10841522131455 | K120616 | 000 |