TELEMETRY SYSTEM, BIOTEL 300

Transmitters And Receivers, Physiological Signal, Radiofrequency

SPACELABS, INC.

The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Telemetry System, Biotel 300.

Pre-market Notification Details

Device IDK781836
510k NumberK781836
Device Name:TELEMETRY SYSTEM, BIOTEL 300
ClassificationTransmitters And Receivers, Physiological Signal, Radiofrequency
Applicant SPACELABS, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeDRG  
CFR Regulation Number870.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-10-30
Decision Date1978-12-04

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