The following data is part of a premarket notification filed by Spacelabs Medical Inc. with the FDA for Modification To Mcare 300 Vital Signs Monitor, Model 91220.
Device ID | K082045 |
510k Number | K082045 |
Device Name: | MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 |
Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
Applicant | SPACELABS MEDICAL INC. 2235 EAST FLAMINGO RD. SUITE 201G Las Vegas, NV 89119 |
Contact | Tim Davis |
Correspondent | Tim Davis SPACELABS MEDICAL INC. 2235 EAST FLAMINGO RD. SUITE 201G Las Vegas, NV 89119 |
Product Code | MHX |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-07-18 |
Decision Date | 2008-08-01 |
Summary: | summary |