SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION

Display, Cathode-ray Tube, Medical

SPACELABS MEDICAL, INC.

The following data is part of a premarket notification filed by Spacelabs Medical, Inc. with the FDA for Spacelabs Medical Multi-disclosure Workstation.

Pre-market Notification Details

Device IDK962811
510k NumberK962811
Device Name:SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION
ClassificationDisplay, Cathode-ray Tube, Medical
Applicant SPACELABS MEDICAL, INC. P.O. BOX 97013 Redmond,  WA  98073 -9713
ContactRuss Garrison
CorrespondentRuss Garrison
SPACELABS MEDICAL, INC. P.O. BOX 97013 Redmond,  WA  98073 -9713
Product CodeDXJ  
CFR Regulation Number870.2450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-18
Decision Date1997-06-24
Summary:summary

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