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 |