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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Pulmonary Function Data
510(k) Number K240293
Device Name STS
Applicant
Techbopulm, Ltd.
6 Ovadya St.
Yad Benyamin,  IL
Applicant Contact Shabtay Negry
Correspondent
ProMedoss, Inc.
3521 Hatwynn Rd.
Charlott,  NC  28269
Correspondent Contact Bosmat Friedman
Regulation Number868.1880
Classification Product Code
BZC  
Subsequent Product Code
BZG  
Date Received02/01/2024
Decision Date 09/17/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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