The following data is part of a premarket notification filed by Spacelabs Medical Inc. with the FDA for Spacelabs Medical Patient Monitors.
| Device ID | K102422 |
| 510k Number | K102422 |
| Device Name: | SPACELABS MEDICAL PATIENT MONITORS |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | SPACELABS MEDICAL INC. 5150 220TH AVE SE Issaquah, WA 98029 |
| Contact | David J Geraghty |
| Correspondent | David 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 | 2010-08-25 |
| Decision Date | 2010-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841522108730 | K102422 | 000 |
| 10841522100215 | K102422 | 000 |
| 10841522100222 | K102422 | 000 |
| 10841522108723 | K102422 | 000 |
| 10841522108716 | K102422 | 000 |
| 10841522107757 | K102422 | 000 |