The following data is part of a premarket notification filed by Spacelabs Medical, Inc. with the FDA for Spacelabs Medical Multiparameter Module 91496.
Device ID | K050175 |
510k Number | K050175 |
Device Name: | SPACELABS MEDICAL MULTIPARAMETER MODULE 91496 |
Classification | Detector And Alarm, Arrhythmia |
Applicant | SPACELABS MEDICAL, INC. 5150 220TH AVE SE P.O. BOX 7018 Issaquah, WA 98027 -7018 |
Contact | Al Van Houdt |
Correspondent | Al Van Houdt SPACELABS MEDICAL, INC. 5150 220TH AVE SE P.O. BOX 7018 Issaquah, WA 98027 -7018 |
Product Code | DSI |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-01-26 |
Decision Date | 2005-03-04 |
Summary: | summary |