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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K781836
Device Name TELEMETRY SYSTEM, BIOTEL 300
Applicant
Spacelabs, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Spacelabs, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.2910
Classification Product Code
DRG  
Date Received10/30/1978
Decision Date 12/04/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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