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 |