SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE

Gas-machine, Anesthesia

SPACELABS MEDICAL, INC.

The following data is part of a premarket notification filed by Spacelabs Medical, Inc. with the FDA for Spacelabs Medical Anesthesia Delivery System (ads) With Pressure Control Mode.

Pre-market Notification Details

Device IDK003663
510k NumberK003663
Device Name:SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE
ClassificationGas-machine, Anesthesia
Applicant SPACELABS MEDICAL, INC. P.O. BOX 97013 Redmond,  WA  98073 -9713
ContactIrene Jaworski
CorrespondentIrene Jaworski
SPACELABS MEDICAL, INC. P.O. BOX 97013 Redmond,  WA  98073 -9713
Product CodeBSZ  
CFR Regulation Number868.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-11-28
Decision Date2001-06-28

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