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 |