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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 K150137
Device Name SpiroThor
Applicant
Cohero Health LLC
335 Madison Avenue, 3rd Floor
New York,  NY  10017
Applicant Contact Melissa Manice
Correspondent
Cohero Health LLC
335 Madison Avenue, 3rd Floor
New York,  NY  10017
Correspondent Contact Paul Dryden
Regulation Number868.1840
Classification Product Code
BZG  
Date Received01/22/2015
Decision Date 05/27/2015
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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