The following data is part of a premarket notification filed by Spacelabs Medical Inc. with the FDA for Elance Vital Signs Monitor And Elance Central Station.
| Device ID | K093501 |
| 510k Number | K093501 |
| Device Name: | ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | SPACELABS MEDICAL INC. 5150 220TH AVE SE Issaquah, WA 98029 |
| Contact | David Geraghty |
| Correspondent | David 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 | 2009-11-12 |
| Decision Date | 2009-11-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841522125744 | K093501 | 000 |
| 10841522113116 | K093501 | 000 |