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 | K050605 |
510k Number | K050605 |
Device Name: | SPACELABS MEDICAL MULTIPARAMETER MODULE 91496 |
Classification | Detector And Alarm, Arrhythmia |
Applicant | SPACELABS MEDICAL INC. 5150 220TH AVE SE PO BOX 7018 Issaquah, Wa, WA 98027 -7018 |
Contact | Al Van Houdt |
Correspondent | Al Van Houdt SPACELABS MEDICAL INC. 5150 220TH AVE SE PO BOX 7018 Issaquah, Wa, WA 98027 -7018 |
Product Code | DSI |
Subsequent Product Code | DPZ |
Subsequent Product Code | DQA |
Subsequent Product Code | DSK |
Subsequent Product Code | DXG |
Subsequent Product Code | DXN |
Subsequent Product Code | FLL |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-03-10 |
Decision Date | 2005-05-03 |
Summary: | summary |