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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilatory effort recorder
510(k) Number K971803
Device Name NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101
Applicant
NEUROTRONICS, INC.
20825 NE 132ND AVE.
WALDO,  FL  32694
Applicant Contact JACK R SMITH
Correspondent
NEUROTRONICS, INC.
20825 NE 132ND AVE.
WALDO,  FL  32694
Correspondent Contact JACK R SMITH
Regulation Number868.2375
Classification Product Code
MNR  
Date Received05/12/1997
Decision Date 11/12/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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