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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K212143
Device Name Neteera 130H/131H Vital Sign Monitoring Sensor
Applicant
Neteera Technologies , Ltd.
Hebrew University Givat Ram Campus,
High-Tech Village - Bldg. 1.1/ P.O. Prof Rokah 2
Jerusalem,  IL 9518702
Applicant Contact Yael Himmel
Correspondent
Hogan Lovells US LLP
1735 Market St., Suite 2320
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number870.2300
Classification Product Code
DRT  
Subsequent Product Code
BZQ  
Date Received07/09/2021
Decision Date 09/28/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT04796181
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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