The following data is part of a premarket notification filed by Spacelabs Medical, Inc. with the FDA for Spacelabs Medical Integrated Clinical Display.
Device ID | K932724 |
510k Number | K932724 |
Device Name: | SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY |
Classification | Display, Cathode-ray Tube, Medical |
Applicant | SPACELABS MEDICAL, INC. 15220 NORTH EAST 40TH ST. P.O. BOX 97013 Redmond, WA 98052 |
Contact | Raymond W Gifford |
Correspondent | Raymond W Gifford SPACELABS MEDICAL, INC. 15220 NORTH EAST 40TH ST. P.O. BOX 97013 Redmond, WA 98052 |
Product Code | DXJ |
CFR Regulation Number | 870.2450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-07 |
Decision Date | 1993-11-05 |