The following data is part of a premarket notification filed by Spacelabs Medical Inc. with the FDA for Spacelabs Medical Full Disclosure System, Model 91810.
Device ID | K063490 |
510k Number | K063490 |
Device Name: | SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810 |
Classification | Computer, Diagnostic, Programmable |
Applicant | SPACELABS MEDICAL INC. 5150 220TH AVE SE Issaquah, WA 98029 |
Contact | David J Geraghty |
Correspondent | David J Geraghty SPACELABS MEDICAL INC. 5150 220TH AVE SE Issaquah, WA 98029 |
Product Code | DQK |
CFR Regulation Number | 870.1425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-11-17 |
Decision Date | 2007-03-15 |
Summary: | summary |