SPACELABS SERIES 90700 PATIENT MONITORS

Electrocardiograph

SPACELABS, INC.

The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Spacelabs Series 90700 Patient Monitors.

Pre-market Notification Details

Device IDK862951
510k NumberK862951
Device Name:SPACELABS SERIES 90700 PATIENT MONITORS
ClassificationElectrocardiograph
Applicant SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth,  CA  91311
ContactHans, P.e.
CorrespondentHans, P.e.
SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth,  CA  91311
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-08-05
Decision Date1986-09-23

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