The following data is part of a premarket notification filed by Spacelabs Medical Inc. with the FDA for Spacelabs Medical Clinical Event Interface, Model 91847.
| Device ID | K062278 |
| 510k Number | K062278 |
| Device Name: | SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847 |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | SPACELABS MEDICAL INC. 5150 220TH AVE SE PO BOX 7018 Issaquah, WA 98027 -7018 |
| Contact | David J Geraghty |
| Correspondent | David J Geraghty SPACELABS MEDICAL INC. 5150 220TH AVE SE PO BOX 7018 Issaquah, WA 98027 -7018 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-07 |
| Decision Date | 2006-09-19 |
| Summary: | summary |