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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 K242290
Device Name DormoTech NLab
Applicant
Dormotech Medical, Ltd.
Yitzhak Rabin 21
Afula,  IL
Applicant Contact Abed Nassir
Correspondent
ProMedic Consulting, LLC
131 Bay Point Dr. NE
St Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.2375
Classification Product Code
MNR  
Subsequent Product Codes
DQA   GWL  
Date Received08/02/2024
Decision Date 01/08/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT06224972
NCT06516809
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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