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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K202837
Device Name GoSpiro
Applicant
Monitored Therapeutics, Inc.
5995 Shier Rings Rd., Suite A
Dublin,  OH  43016
Applicant Contact Michael Taylor
Correspondent
Monitored Therapeutics, Inc. C/O Promedic, LLC
131 Bay Point Dr. NE
St Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.1840
Classification Product Code
BZG  
Date Received09/25/2020
Decision Date 12/04/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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