SPACELABS MODEL 90201 HOLTER RECORDER

Recorder, Magnetic Tape, Medical

SPACELABS, INC.

The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Spacelabs Model 90201 Holter Recorder.

Pre-market Notification Details

Device IDK844940
510k NumberK844940
Device Name:SPACELABS MODEL 90201 HOLTER RECORDER
ClassificationRecorder, Magnetic Tape, Medical
Applicant SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth,  CA  91311
ContactAllen M Hans
CorrespondentAllen M Hans
SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth,  CA  91311
Product CodeDSH  
CFR Regulation Number870.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-12-20
Decision Date1985-02-14

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