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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Breathing Frequency
510(k) Number K864261
Device Name MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR
Applicant
Bio-Dyne, Inc.
36 Higgins Dr.
Milford,  CT  06460
Applicant Contact JAMES WALLS
Correspondent
Bio-Dyne, Inc.
36 Higgins Dr.
Milford,  CT  06460
Correspondent Contact JAMES WALLS
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received10/29/1986
Decision Date 03/27/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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