The following data is part of a premarket notification filed by Spacelabs Medical Inc. with the FDA for Mcare 300 Vital Signs Monitor, Model 91220.
| Device ID | K062095 |
| 510k Number | K062095 |
| Device Name: | MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | SPACELABS MEDICAL INC. 5150 220TH AVE SE PO BOX 7018 Issaquah, Wa, WA 98027 -7018 |
| Contact | David J Geraghty |
| Correspondent | David J Geraghty SPACELABS MEDICAL INC. 5150 220TH AVE SE PO BOX 7018 Issaquah, Wa, WA 98027 -7018 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-24 |
| Decision Date | 2006-09-29 |
| Summary: | summary |