MODEL 90478 & 90479 TELEMETRY REC. MODULE&HOUSING

Detector And Alarm, Arrhythmia

SPACELABS MEDICAL, INC.

The following data is part of a premarket notification filed by Spacelabs Medical, Inc. with the FDA for Model 90478 & 90479 Telemetry Rec. Module&housing.

Pre-market Notification Details

Device IDK925510
510k NumberK925510
Device Name:MODEL 90478 & 90479 TELEMETRY REC. MODULE&HOUSING
ClassificationDetector And Alarm, Arrhythmia
Applicant SPACELABS MEDICAL, INC. 925 SHERMAN AVE. Hamden,  CT  06514
ContactRaymond W Gifford
CorrespondentRaymond W Gifford
SPACELABS MEDICAL, INC. 925 SHERMAN AVE. Hamden,  CT  06514
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-10-30
Decision Date1994-10-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10841522108365 K925510 000

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